AstraZeneca is a global, 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.

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.

As the Principal PET (Process Execution Team) Engineer, you will be responsible for ensuring one technical process exists within the PET. This includes equipment, materials, process, and procedures with applicable validation. You will be leading improvement initiatives as the technical expert and acting as a line of support for project related work. This role is responsible for maintaining a strong relationship with PT&D and Quality areas, as well as, collaborating within the PET/Facility and with other PET Engineers. SME for technical NPI activities within the Pack PET and acts as a liaison between the PET Technical Team and the NPI Team to ensure the pack lines are ready for NPI launches on time.

Main Responsibilities:

• Supports, coaches, and mentors PET Engineers to facilitate the following continuous improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment
• Supports the NPI & BAU LRF / GAZELLE workflows by overseeing MIF/artwork assessments and any necessary documentation or equipment updates, including but not limited to SOP updates, equipment and line specification updates, equipment and/or process validation, etc.
• SME for NPI tech transfer activities, both transfer in and transfer out.  Acts as the single point of contact for NPI readiness within the PET Technical Team; plans and facilitates packaging line readiness and collaborates with the NPI Facilitator, planning, Process Facilitators, and other stakeholders as the key technical resource to ensure all milestone launch dates are met and packaging lines are validated and ready for NPI launch on time.
• Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports
• Coordinate and support PET’s/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence. Manages life cycle of assets.
• Maintain external technical relationships and collaborates with equipment and material suppliers
• Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations
• Perform and maintain risk management activities for new and existing processes / equipment
• Initiate deviations and performs/facilitates the technical investigations and assessment of impacts
• Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms. Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests
• Provides input and develops user requirements for new asset procurement
• Provide engineering and project management services

• Assist in the development of project justification and engineering proposals including providing input for capital planning process
• Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
• Perform routine validation and periodic reviews activities
• Works collaboratively within PET as well as with other PET Engineers and Technology Community i.e. PT&D, AZ Bio, global colleagues, etc.
• Supports and leads technical trouble shooting.
• On-call support as required
• Key contact for regulatory inspections as technical process owner
• Participates in annual product review process
• Participates in biennial critical systems review process.
• Responsible for process validation required as a result of changes to validated processes within the PET.

Minimum Requirements:

• BS in Engineering, or related science
• Minimum 10 years of experience in GMP or regulated production environment
• Direct experience and expertise in NPI and tech transfer.
• Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics
• Expertise in at least one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation
• Ability to develop proficiency in all of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation, NPI
• Ability to coach and mentor peers

Preferred Background:

• Advanced technical degree or professional certification
• Proven experience leading a team of technical personnel
• Project management
• Uses their insight to challenge and adapt current approaches/ways of doing things
• Experience in Six Sigma/ analytical trouble shooting skills
• Experience working in a LEAN manufacturing environment

Apply Now!

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.

Date Posted

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.