Process Engineer III - Filling

Position Summary & Responsibilities As a Process Engineer III on the MSAT team, you will lead the technical commissioning and delivery of state‑of‑the‑art sterile fill‑finish assets, including advanced robotics and an isolator filling line. Process Capability: Ensure a single technical process with centerlines, critical process parameters (CPPs), and material fit‑for‑use; ensure operating procedures are clear and deliver a capable process. Continuous Improvement: Lead efforts in changeover reduction, yield improvements, OEE optimization, maintenance reliability, and waste reduction for automated pharmaceutical manufacturing equipment. Technology Transfer: Ensure success criteria for technology transfer and validation are clear and that processes are capable of merging into manufacturing/Facility operations. Technical Documentation: Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports. Asset Management: Coordinate Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilisation, efficiencies, and obsolescence; manage the full lifecycle of the asset. External Collaboration: Maintain external technical relationships and collaborate with equipment and material suppliers. Change Management: Identify, develop, and manage the implementation of change controls to improve processes. Risk Management: Perform and maintain risk management activities for both new and existing processes and equipment. Investigations: Initiate deviations and facilitate technical investigations and impact assessments. Address root causes identified in investigations. Documentation Review: Author and review documents such as SOPs, Batch Records, and Rework procedures. Quality Compliance: Review and approve validation and change control documents including master plans, protocols, summary reports, and change requests. Project Management: Provide engineering and project management services, including project justification and capital planning input. Training Support: Identify and support technical training requirements for Operations, Engineering, and Maintenance for new and existing processes/equipment. Validation Oversight: Perform routine validation and periodic review activities. Troubleshooting: Support and lead technical troubleshooting and provide on‑call support as required. Regulatory Support: Serve as a key contact for regulatory inspections as the technical process owner. System Reviews: Participate in the annual product review and biennial critical systems review process. Process Control: Manage process validation required due to changes in validated manufacturing processes. Minimum Qualifications Proven experience in GMP or regulated production environments. Training or experience in mechanics, hydraulics, pneumatics, vacuum technology, electronics, PLCs, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, and applied statistics. Proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation. Preferred Qualifications Bachelor’s degree in Chemical, Mechanical, Electrical, Industrial, Automation, Mechatronics, Bioengineering, Pharmaceutical Engineering, or related science. Project management experience. Ability to challenge and adapt current approaches. Experience in Six Sigma / analytical troubleshooting. Experience working in a LEAN manufacturing environment. Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation. Ability to coach and mentor peers. Work Schedule 8 hours per day, Monday–Friday, with off‑shift support as needed. Equal Employment Opportunity Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, protected veteran status, disability, or any other characteristic protected by law. Requests for reasonable accommodation are accepted throughout the recruitment process. Sponsorship or support for work authorization, including visas, is not available for this position. #J-18808-Ljbffr Resilience