AstraZeneca Pharmaceuticals LP Senior Process/Reliability Engineer in West Chester, Ohio

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.

The Senior PET Engineer, Bulk is responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials, process, and procedures with applicable validation. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as, collaborating within the PET/Facility and with other PET Engineers. Serves as the single point of contact for all technical issues.

Essential Job Functions:

  • Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process

  • Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment

  • Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process

  • 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.Technology and Engineering, global colleagues

  • 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

  • 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

  • Minimum 4 years experience in GMP or regulated production environment

  • 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

  • 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

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.