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Plats: Gaithersburg, Maryland, USA
Jobb-id R-057230
Datum inlagd: 07/30/2019

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 the exceptional skills of people from all over the globe.

As a Packaging Engineer in Gaithersburg, MD, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing the lives of patients. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

You will be responsible for a range of packaging systems and packaging engineering technical initiatives, process improvements and process management activities. Activities include planning, performing, and implementing process improvement initiatives, in addition to ownership of operational processes and package development projects.

Main Responsibilities:

  • Primary point of contact with CMOs (Contract Manufacturing Organizations) for BAU (Business As Usual) management of AZ’s serialization/traceability program.
  • Ensure CMOs have the capability to deliver within necessary timelines, ensure data connections are in place, provide oversight on CMO delivery plans, risk/issue management.
  • Collaborate with AZ’s product security lead to assess and ensure compliance to product security processes and practices at internal and external label and pack sites.
  • Own and manage change records, issue resolution, deviations and CAPAs.
  • Manage artwork/labelling development and approval.
  • Author, review and approve packaging component specifications.
  • Review Bills of Material.
  • Review Master Batch Records.
  • Author and review protocols and technical reports.
  • Design secondary packaging components.
  • Coordinate simulated distribution and thermal profile testing of packaging systems to ensure product quality in transit.
  • Provide critical technical analysis of packaging systems and processes.
  • Other activities
  • The role holder may be required to manage other packaging, labelling and product security related projects within Bio-Ops

Minimum Requirements:

  • Bachelors degree in packaging engineering or similar field
  • Minimum of 2 years packaging engineer experience, preferable in pharma or bio
  • Experience with packaging and labelling
  • Good high-level understanding of E2E Traceability Processes
  • Pharmaceutical/biotechnology manufacturing, operations
  • Bachelor’s degree in packaging engineering, supply chain, packaging or business
  • Data analysis skills
  • Microsoft office tools
  • Good communications skills, including written, oral, and presentation
  • Strong project management skills
  • Experience with process improvement initiatives
  • Knowledge of good manufacturing practice (GMP) qualifications

Preferred Skills and Experience:

  • Experience with serialization and/or product security
  • Master’s Degree in engineering or business
  • Lean six sigma green belt
  • Certification in business process management
  • Certified Supply Chain Professional (CSCP)
  • Well connected to internal Bio/GES, CMOs and Global teams
  • Understanding of level 1-4 serialization systems
  • Good understanding of regulatory requirements
  • Knowledge of the AZ BPM framework

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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 the exceptional skills of people from all over the globe.

As a Packaging Engineer in Gaithersburg, MD, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing the lives of patients. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

You will be responsible for a range of packaging systems and packaging engineering technical initiatives, process improvements and process management activities. Activities include planning, performing, and implementing process improvement initiatives, in addition to ownership of operational processes and package development projects.

Main Responsibilities:

  • Primary point of contact with CMOs (Contract Manufacturing Organizations) for BAU (Business As Usual) management of AZ’s serialization/traceability program.
  • Ensure CMOs have the capability to deliver within necessary timelines, ensure data connections are in place, provide oversight on CMO delivery plans, risk/issue management.
  • Collaborate with AZ’s product security lead to assess and ensure compliance to product security processes and practices at internal and external label and pack sites.
  • Own and manage change records, issue resolution, deviations and CAPAs.
  • Manage artwork/labelling development and approval.
  • Author, review and approve packaging component specifications.
  • Review Bills of Material.
  • Review Master Batch Records.
  • Author and review protocols and technical reports.
  • Design secondary packaging components.
  • Coordinate simulated distribution and thermal profile testing of packaging systems to ensure product quality in transit.
  • Provide critical technical analysis of packaging systems and processes.
  • Other activities
  • The role holder may be required to manage other packaging, labelling and product security related projects within Bio-Ops

Minimum Requirements:

  • Bachelors degree in packaging engineering or similar field
  • Minimum of 2 years packaging engineer experience, preferable in pharma or bio
  • Experience with packaging and labelling
  • Good high-level understanding of E2E Traceability Processes
  • Pharmaceutical/biotechnology manufacturing, operations
  • Bachelor’s degree in packaging engineering, supply chain, packaging or business
  • Data analysis skills
  • Microsoft office tools
  • Good communications skills, including written, oral, and presentation
  • Strong project management skills
  • Experience with process improvement initiatives
  • Knowledge of good manufacturing practice (GMP) qualifications

Preferred Skills and Experience:

  • Experience with serialization and/or product security
  • Master’s Degree in engineering or business
  • Lean six sigma green belt
  • Certification in business process management
  • Certified Supply Chain Professional (CSCP)
  • Well connected to internal Bio/GES, CMOs and Global teams
  • Understanding of level 1-4 serialization systems
  • Good understanding of regulatory requirements
  • Knowledge of the AZ BPM framework

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

Packaging Engineer - Operations
Tillverkning

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