Process Engineer III - Filling

Role Overview

We are looking for a Mission‑driven engineer to help us deliver with 'First‑Pass Accuracy' and industry‑leading technical standards in our MSAT team. The Process Engineer III leads improvement initiatives and serves as the first line of support for all project‑related work.

• Process Capability:
  Ensure one technical process with centerlines, CPPs, and material fit‑for‑use; clear operating procedures and 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 processes are capable of merging into Manufacturing/Facility operations.
• Technical Documentation:
  Generate a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
• Asset Management:
  Coordinate Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, 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.

• Proven Experience in GMP or regulated production environment
• Training or experience in mechanics, hydraulics, pneumatics, vacuum technology, electronics, PLCs, HMI, historian/reporting, computerised 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, applied statistics
• Proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation

• Bachelor's Degree in Chemical, Mechanical, Electrical, Industrial, Automation, Mechatronics, Bioengineering, Pharmaceutical Engineering, or related science
• Project management experience
• Critical thinking and adaptability to challenge current approaches
• Experience in Six Sigma and analytical troubleshooting
• Experience working in a Lean manufacturing environment
• Expertise in more than one of the disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation
• Mentoring skills

8 hours – Monday through Friday with off‑shift support as needed. Schedule is subject to change at the employer’s discretion.

Sterile Manufacturing, Biopharma MSAT, Asset Delivery, Aseptic Processing, Sterile Fill‑Finish, CDMO, Technology Transfer, Annex 1 Compliance, RABS, Isolator Technology, Process Validation,…