Packaging Operator
Astra Zeneca, Newark, DE
Job ID: R-162037
Date posted: 22/03/2023
Job Type – Full time
Shift and Schedule – 8 hours shift, weekend availability, Monday to Friday
Would you like to work in a fast-paced team environment in a company that follows science and turns ideas into life-changing medicines? Are you searching for career growth and development in a production environment with competitive salaries and benefits? If so, the Packaging Operator position would be an excellent fit for you!
The AstraZeneca Newark Supply Site was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for the global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and a dining center.
The operating hours for this position are first, second, and third shift, Monday through Friday with 8-hour shifts. Shift hours differ based on what area you are assigned. You “may” train on the first shift.
The Packaging Operator produces packaged pharmaceutical products in a safe and efficient manner, complying with cGMP’s, SOPs, and site safety procedures.
What you will do:
- Operate packaging equipment in a safe and efficient manner by supplying equipment with components and products.
- Perform detection system challenges on the applicable equipment.
- Perform changeover, set up, troubleshooting, and basic maintenance of packaging equipment.
- Clean and purge packaging equipment.
- Accountable for accurately documenting packaging and cleaning activities.
- Work effectively in teams to meet monthly demand requirements and identify areas for continuous and efficient improvements.
- Must be able to work various shifts, weekends, alternative schedules when production demands require.
- High School Diploma / GED
- Ability to communicate effectively (verbal and written) and ability to work collaboratively in a team environment
- Ability and confidence to work in a digital environment
- Ability to lift up to 30 lbs.
- Experience in a production environment
- Understand the basics of how machines operate
- Knowledge of pharmaceutical production (i.e. cGMPs)
- Associates Degree or higher
Find out more on Social Media:
- LinkedIn https://www.linkedin.com/company/1603/
- Facebook https://www.facebook.com/astrazenecacareers/
- Instagram https://www.instagram.com/astrazeneca/?hl=en
- About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
Regional Technical Sustainability Lead
Would you like to apply your experience in Pharmaceutical services technology and processes and your extensive knowledge of utilities supply in a company that follows the science and brings medicine to patients? If so the Regional Technical Sustainability Lead at AstraZeneca is an excellent fit!
This role can be based in Newark, DE; Mt Vernon, IN; Coppell, TX; Wilmington, DE or in Gaithersburg, MD. This is an individual contributor role.
At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organization. This means we’re opening up new ways to work, groundbreaking methods and bringing unexpected teams together. Join us on our journey of building a new type of organization to reset expectations of what a bio-pharmaceutical company can be!
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
This role will provide technical leadership and subject matter expertise to all sites (Operations, R&D and Commercial) in the Americas both as an expert designing and implementing sustainable technologies and through leadership of relevant technical and project teams. The Sustainability Lead will be responsible for the technical appraisals including oversight and delivery of key major capital projects for the Americas region, and it will ensure all sites are aligned to the Ops 2025 (soon to be 2030) bold ambition for sustainability through implementing improvements and sharing best practices between sites.
The Sustainability Lead will report into the Americas supply region and will act as a key liaison with sites & other regions, handle all aspects of capital project management including the development of scope, budget, and timeline for all Sustainability engineering projects, and controlling the small capital process in the Americas supply region.
What you will do:
This role can be based in Newark, DE; Mt Vernon, IN; Coppell, TX; Wilmington, DE or in Gaithersburg, MD. This is an individual contributor role.
At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organization. This means we’re opening up new ways to work, groundbreaking methods and bringing unexpected teams together. Join us on our journey of building a new type of organization to reset expectations of what a bio-pharmaceutical company can be!
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
This role will provide technical leadership and subject matter expertise to all sites (Operations, R&D and Commercial) in the Americas both as an expert designing and implementing sustainable technologies and through leadership of relevant technical and project teams. The Sustainability Lead will be responsible for the technical appraisals including oversight and delivery of key major capital projects for the Americas region, and it will ensure all sites are aligned to the Ops 2025 (soon to be 2030) bold ambition for sustainability through implementing improvements and sharing best practices between sites.
The Sustainability Lead will report into the Americas supply region and will act as a key liaison with sites & other regions, handle all aspects of capital project management including the development of scope, budget, and timeline for all Sustainability engineering projects, and controlling the small capital process in the Americas supply region.
What you will do:
- Define the Regional Sustainability program and roadmap across the seven (7) sites in Americas Supply and provides sustainability technical leadership and subject matter expertise to the region. Develop and own the regional natural resource (waste, water, energy, recycle) glide-paths to ensure they are accurately executed in order to achieve our AZ sustainability ambitions.
- Function as the HVAC Optimization SME for Americas Supply to meet and exceed AZ’s sustainability targets. Participates and inputs into operational strategic and planning meetings to help sites develop their Site Master Plans with a sustainability mindset.
- Lead or provide expert support to major sustainability improvement programs and other key sustainability projects in region, including Capital project management (e.g. electric boilers project at Mt Vernon). Partner with sites, contractors and consultants to establish strategic feasibility, engineering design and construction scope documents for key projects.
- In collaboration with site sustainability leaders, responsible for the Annual Capital Project Budget and the development, submission, and tracking of all NRF requests. Lead the Facilities and Engineering leaders CoE regional prioritization and coordination of Small Capital spend.
- Act as specialist expert in implementing new technologies and strategies, and communicates strategic vision with respect to achieving the AZ sustainability ambitions. Set aspirational sustainability goals, provide thought leadership and direction to engineering & project teams in a matrix organization. Liaise with and advise Global Engineering on Technical Standards for sustainability projects.
- Communicate our sustainability ambition roadmap, emerging trends, and progress to the broader AZ network. Networks across the business and experts to identify business improvement opportunities and demonstrates personal ownership and accountability for results.
- Bachelors of Science in an appropriate field is required.
- Minimum 2 years of experience in Pharmaceutical services technology & processes.
- Minimum of 5 years of extensive knowledge of utilities supply markets and US local regulations.
- Experience in construction project management with an ability to balance opposing priorities
- Knowledge of cGMPs, SOPs, Federal, and local regulatory requirements
- Shown ability to develop short-term and long-term strategic plans to meet business direction/initiatives and follow all legal obligations
- Demonstrated ability to influence and interact with all levels across the organization
- Strong negotiating skills with contract services relative to prices and technology
- Strong Technical engineering leadership and interpersonal relationship skills
- Ability to travel 25%
- Advanced degree in a scientific field
- Expert reputation within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations in utilities.
- LinkedIn https://www.linkedin.com/company/1603/
- Facebook https://www.facebook.com/astrazenecacareers/
- Instagram https://www.instagram.com/astrazeneca/?hl=en
Regional Lean Practitioner - TPM
AstraZeneca, Newark, DE,
Job ID: R-162021
Date posted: 04/04/2023
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Regional Lean Leader, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Job Description
The Regional Lean Practitioner—TPM is the Americas’ business process owner for Total Productive Maintenance, driving successful deployment, building capability and implementing Total Productive Maintenance (TPM) across our supply sites. The individual will be a lean practitioner with expert proficiency in TPM, possessing the ability to develop a TPM strategy and roadmap and spearhead both strategic and tactical implementation at site and process levels. The incumbent must possess fundamental lean knowledge to build a strong lean-digital foundation prior to applying TPM principles. Activities to include roadmap development, data collection, planning, execution, staff coaching, knowledge transfer, etc. The TPM Lead will work closely with plants and global resources to drive loss elimination to meet/exceed business objectives, demonstrating bottom-line impact of TPM implementation. Success will be measured by metrics improvements, including downtime and Overall Equipment Efficiency (OEE) improvements. Expected travel will be between 25% and 40%.
Job Responsibilities
Job Description
The Regional Lean Practitioner—TPM is the Americas’ business process owner for Total Productive Maintenance, driving successful deployment, building capability and implementing Total Productive Maintenance (TPM) across our supply sites. The individual will be a lean practitioner with expert proficiency in TPM, possessing the ability to develop a TPM strategy and roadmap and spearhead both strategic and tactical implementation at site and process levels. The incumbent must possess fundamental lean knowledge to build a strong lean-digital foundation prior to applying TPM principles. Activities to include roadmap development, data collection, planning, execution, staff coaching, knowledge transfer, etc. The TPM Lead will work closely with plants and global resources to drive loss elimination to meet/exceed business objectives, demonstrating bottom-line impact of TPM implementation. Success will be measured by metrics improvements, including downtime and Overall Equipment Efficiency (OEE) improvements. Expected travel will be between 25% and 40%.
Job Responsibilities
- Responsible for the region’s Machine Improvement strategy (TPM, SMED, etc.) and facilitate implementation across the region.
- Apply AZ Lean Model to drive Genba-level execution and deliver value and productivity targets.
- Serve as regional TPM/lean expert to spearhead, support, and scale business solutions across the region.
- Delivery of regional, site and functional metrics (SQSCP) as applicable
- Engages and leads sites, regional and functional resources to define and deploy TPM and broader lean-digital processes and practices.
- Works with regional and functional leaders to ensure adequate capabilities within the region, sites and functions to effectively embed lean-digital (specifically, TPM) as “business as usual.”
- Ensures that site, regional and functional lean implementation plans and business processes align with global strategies and adhere to expected standards of practices.
- Drives standard and consistency in lean-digital implementation across sites, leveraging and incorporating both internal and external best practices.
- Improve and uplift overall AZ ways of working by challenging processes and practices that do not add value or do not align with the region’s priorities.
- Aligns implementation of AZSS ways of working to key business needs and results.
- Represents the Lean Program as member of relevant cross-functional AZ and external Lean forums/organizations/communities of practice.
- Supports with coaching and mentoring of local site lean leads, GMs and teams.
- Conduct activities and interactions consistent with company values and in compliance with the Code of Conduct and supporting policies and standards relevant to your role.
- Complete all required training on the AZ Code of Conduct and supporting policies and standards on time. Report potential issues of non-compliance.
- Be an inclusive leader and support execution of region’s sustainability ambitions.
- Expert-level TPM and SMED experience and skills
- Good lean-digital acumen
- Ability to pull through value of lean-digital (TPM) efforts across sites and the region.
- Ability to collaborate with all levels of the organization to help understand and overcome existing challenges.
- Ability to manage change and deliver results; hands-on execution skills.
- Effective, engaging communicator; able to connect with different levels and audiences within the organization.
- Educated to undergraduate degree level or higher in a Manufacturing, Engineering or related technical/business discipline
- Possesses 5 to 7 years of TPM/Lean-digital experience in a fast-pace, structured lean environment or possesses a good balance of experience and advanced education.
- Demonstrates significant industry related experience in fundamental lean methodologies such as Strategy Deployment (i.e. Hoshin Kanri), Value Stream Mapping, Standard Work, Daily Management or Tier Accountability, Leader Standard Work, SMED, TPM, etc.
- A track record of delivering business impact and sustained change and demonstrated understanding and application of change management principles.
- Expertise in process & project management and improvement
- Expertise in the application of analytical problem-solving methodology
- Broad understanding of supply chain processes
- Understanding of Good Automated Manufacturing Practice, current Good Manufacturing Practice and regulations as defined by local regulatory bodies
- In depth knowledge of Lean best practice from the external world and other related industries
Regional Lean Leader
AstraZeneca, Newark, DE
Job ID: R-162017
Date posted: 04/04/2023
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Regional Lean-Digital Practitioner, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Job Description
The Regional Lean-Digital Practitioner will work with site and functional leaders across the Americas to drive lean-digital implementation at the process and systems levels through application of lean-digital principles. The incumbent will take a hands-on, value-creating approach to lean execution. He or she will demonstrate understanding of lean principles via real-life, tangible metrics improvement that corresponds with business challenges. There will be a dual focus on process and results, including deployment of site and regional strategies and execution support by way of workshop/kaizen facilitation, lean roadmap development, mentoring, coaching and training on various lean methodologies. He or she will build rapport across the organization and influence site and region executives as well as junior associates on the production lines. Expected travel will be between 35% and 50%.
Demonstrated impact will be measured by:
Job Description
The Regional Lean-Digital Practitioner will work with site and functional leaders across the Americas to drive lean-digital implementation at the process and systems levels through application of lean-digital principles. The incumbent will take a hands-on, value-creating approach to lean execution. He or she will demonstrate understanding of lean principles via real-life, tangible metrics improvement that corresponds with business challenges. There will be a dual focus on process and results, including deployment of site and regional strategies and execution support by way of workshop/kaizen facilitation, lean roadmap development, mentoring, coaching and training on various lean methodologies. He or she will build rapport across the organization and influence site and region executives as well as junior associates on the production lines. Expected travel will be between 35% and 50%.
Demonstrated impact will be measured by:
- Leadership: Both strategic and tactical (site & functions)
- Value: Drive tangible, bottom-line impact
- Maturity: Systems-driven improvements
- Performance: Evidenced by metric improvement over time.
- Culture: Coach, mentor and develop others in the organization to become lean leaders.
- Lean Digital: Advance Ops 2025/2030 Lean-Digital strategy
- Influences and assists sites with preparation and development of lean-digital strategies using Hoshin Kanri, Value Stream Mapping, A3 and other relevant methodologies; support with execution of site lean-digital roadmaps.
- Apply AZ Lean Model to drive Genba-level execution and deliver value and productivity targets.
- Serve as regional expert to spearhead, support, and scale business solutions across the region.
- Delivery of regional, site and functional metrics (SQSCP) as applicable
- Engages and leads sites, regional and functional resources to define and deploy lean-digital processes and practices.
- Works with regional and functional leaders to ensure adequate capabilities within the region, sites and functions to effectively embed lean-digital as “business as usual.”
- Ensures that site, regional and functional lean implementation plans and business processes align with global strategies and adhere to expected standards of practices.
- Drives standard and consistency in lean-digital implementation across sites, leveraging and incorporating both internal and external best practices.
- Improve and uplift overall AZ ways of working by challenging processes and practices that do not add value or do not align with the region’s priorities.
- Aligns implementation of AZSS ways of working to key business needs and results.
- Represents the Lean Program as member of relevant cross-functional AZ and external Lean forums/organizations/communities of practice.
- Supports with coaching and mentoring of local site lean leads, GMs and teams.
- Conduct activities and interactions consistent with company values and in compliance with the Code of Conduct and supporting policies and standards relevant to your role.
- Complete all required training on the AZ Code of Conduct and supporting policies and standards on time. Report potential issues of non-compliance.
- Be an inclusive leader and support execution of region’s sustainability ambitions.
- Good lean-digital acumen
- Ability to pull through value of lean-digital efforts across sites and the region.
- Ability to collaborate with all levels of the organization to help understand and overcome existing challenges.
- Ability to manage change and deliver results; hands-on execution skills.
- Effective, engaging communicator; able to connect with different levels and audiences within the organization.
- Educated to undergraduate degree level or higher in a Manufacturing, Engineering or related technical/business discipline
- Possesses 7 to 10 years plus of experience in a fast-pace, structured lean environment or possesses a good balance of experience and advanced education.
- Demonstrates significant industry related experience in fundamental lean methodologies such as Strategy Deployment (i.e. Hoshin Kanri), Value Stream Mapping, Standard Work, Daily Management or Tier Accountability, Leader Standard Work, SMED, TPM, etc.
- Driven, self-starter and motivated individual who works well in a team setting.
- A track record of delivering business impact and sustained change and demonstrated understanding and application of change management principles.
- Expertise in process & project management and improvement
- Expertise in the application of analytical problem-solving methodology
- Broad understanding of supply chain processes
- Understanding of Good Automated Manufacturing Practice, current Good Manufacturing Practice and regulations as defined by local regulatory bodies
- In depth knowledge of Lean best practice from the external world and other related industries
Industrial Maintenance Mechanic
Location Newark, Delaware
Job ID: R-160039
Date posted: 12/04/2023
Are you seeking an excellent opportunity in a global pharmaceutical company to apply and grow your industrial maintenance mechanic experience? If you enjoy performing Preventive, Corrective, and Predictive Maintenance, mechanical and electrical equipment troubleshooting and repairs, and applying Lean Leadership behaviors toward continuous improvement, then an Industrial Mechanic position would be a great fit for you.
The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for the global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The Industrial Mechanic is responsible for multi-craft maintenance activities in one of the assigned functional areas:
Find out more on Social Media:
The Industrial Mechanic is responsible for multi-craft maintenance activities in one of the assigned functional areas:
- Oral solid dose tablet formulation to ensure production and/or facility equipment operates efficiently and in compliance with FDA requirements.
- Site maintenance, facilities, utilities, and warehouse to ensure equipment operates efficiently and in compliance with all applicable regulatory requirements.
- Packaging operations to ensure production and/or facility equipment operates efficiently and in compliance with FDA requirements.
- Perform Preventive and Predictive Maintenance on equipment in the assigned areas including: Inspections, general maintenance, scheduled overhauls, and duct cleanings
- Use analytical troubleshooting skills to recognize system and equipment problems, identify true cause, and recommend/ implement solutions that prevent problem reoccurrence
- Perform mechanical and electrical equipment repairs in the assigned area including set-up/change-over, routine adjustments and fabrication
- Perform and document work in compliance with SOP’s, Safety Health & Environment (SHE) standards and Good Manufacturing Practices (GMP’s) including work orders, PM’s, logbooks, and permits
- Respond to multiple equipment/production problems and prioritize or change assignments as needed to meet production demands
- Support installation and qualification of new equipment and systems
- Work with Supervisors, Operators, Engineers, and other Mechanics to identify and implement opportunities to improve equipment/production efficiencies.
- Participate in cross-functional teams as assigned to support continuous improvement or equipment installation/modification
- Provide training/coaching as needed to other mechanics and operators
- High School Diploma or equivalent (GED)
- Minimum three (3) years of industrial maintenance experience
- Must be able to work or be on-call as needed during other/off shifts and weekends when facility, production and/or equipment maintenance coverage is needed
- State accredited Journeyman
- Associates degree in a technical subject area, completion of a technical school program, or equivalent formal technical education
- Field experience and demonstrated proficiency in any of the following subject matter areas: mechanical maintenance of production equipment, utility systems maintenance and repair, electrical maintenance, instrumentation and controls, and/or mechanical fabrication/machine shop.
- Demonstrated understanding and operational familiarity with PC/PLC control systems.
- Demonstrated understanding of pharmaceutical cGMP maintenance practices
- Facilities and utilities equipment maintenance experience including HVAC, boilers, air compressors, purified water, and electrical distribution systems
- Material Handling equipment maintenance experience including automated cranes, conveyers, sorting systems, and forklifts
Find out more on Social Media:
- LinkedIn https://www.linkedin.com/company/1603/
- Facebook https://www.facebook.com/astrazenecacareers/
- Instagram https://www.instagram.com/astrazeneca/?hl=en
- About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
Device Quality Manager- Global Operations US
Locations: Gaithersburg, Maryland, Coppell, Texas, Newark, Delaware, Wilmington, Delaware, Mount Vernon, Indiana
Job ID: R-157340
Date posted: 29/01/2023
Device Quality Manager- Operations
Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? AstraZeneca is a science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
The Device Quality Manager will be responsible for leading quality planning and improvement activities, partnering with sites and global functions and influencing at multiple levels of the organization in order to ensure our device products remain in compliance with the applicable regulations. They will provide specialist quality leadership and support for commercialized Combination Products and Medical Devices. This role will work with internal and external partners to provide portfolio-level device quality support.
Main Responsibilities:
Main Responsibilities:
- Provide Device Quality support to Device Technical Leads of above-site / multi-site Combination Products and Medical Devices in support of device compliance maintenance activities (e.g Design History File, Device Master Records etc.).
- Provide Device Quality support for above-site / multi-site change assessments for Combination Products and Medical Devices, defining quality strategies, priorities and plans as required for evaluation activities.
- Provide Device Quality expertise in support of Site Device Quality SMEs.
- Support Supplier Quality Managers by providing Device Quality expertise to address risk management, change control, quality or auditing activities.
- Lead or support above-site / multi-product responses to Device-related issues to ensure a coordinated and consistent approach.
- Provide above-site / multi-site Device Quality support for the handling and trending of device related complaint records.
- Provide Device related Quality support during the transfer of both new projects and established products to internal and external manufacturing sites.
- Support actions required as a result of updates or new standards or requirements.
- Identify and deliver improvement opportunities related to the Combination Product and Medical Device Quality Management System, ensuring compliance to all applicable regulations.
- BS and/or MS in engineering or equivalent technical discipline
- Seasoned experience working with Combination Products and/or Medical Devices, ideally in a Post-Production (Operations) setting.
- Extensive knowledge of both US and International device requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC).
- Understanding of the overall drug and device development and commercialization process from development, launch and through life cycle management.
- A good technical knowledge of one of the key portfolio technology areas (parenteral, inhalation, software).
- Evidence of excellent communication skills and building excellent relationships with internal and external customers.
- Project management skills with a track record of successful delivery within a matrix organization.
- Ability to develop solutions to a diverse range of problems using structured problem-solving tools and sound analytical and conceptual thinking
- LinkedIn https://www.linkedin.com/company/1603/
- Facebook https://www.facebook.com/astrazenecacareers/
- Instagram https://www.instagram.com/astrazeneca/?hl=en
- About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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Awesome!