Supports technology transfer, process implementation, commissioning, qualification, and validation within GMP-regulated sterile manufacturing. Leads CQV protocols and reports, develops SOPs and validation strategies, supports design reviews, risk assessments, change controls, vendor qualification, troubleshooting, and process optimization. Provides technical support for fill-finish operations including vial filling, prefilled syringes, lyophilization, sterile filtration, aseptic processing, bulk products, and plasma manufacturing while coordinating Engineering, Quality, Operations, Automation, and Regulatory stakeholders.
POSITION SUMMARY:
The MS&T Process Engineer role is to support technology transfer, process implementation, commissioning, qualification, and validation activities within a GMP-regulated manufacturing environment. This role focuses on sterile manufacturing, fill-finish operations, and process technology projects while collaborating with cross-functional teams to deliver compliant and efficient manufacturing solutions.
The incumbent is also responsible and accountable for the execution of the project and PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development”.
DUTIES AND RESPONSIBILITIES:
- Lead technology transfer activities and support facility, process, and technology upgrades.
- Author, execute, and review DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports.
- Develop CQV documentation, SOPs, validation strategies, and final reports.
- Support design reviews, risk assessments, change controls, and process optimisation initiatives.
- Coordinate Engineering, Quality, Operations, Automation, and Regulatory teams through qualification, commissioning, and operational readiness activities.
- Support fill-finish manufacturing processes including vial filling, PFS, lyophilisation, sterile filtration, aseptic processing, bulk product, and plasma manufacturing.
- Provide technical support for vendor qualification, FAT/SAT, troubleshooting, and continuous improvement projects.
DEMONSTRATED COMPETENCIES:
- Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
- Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
- Organization – Strong organization skills are needed to assist in personnel, budgets, and planning for each project.
- Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
- Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
- Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
- Bachelor’s Degree in Engineering or relative Life Science degree preferred.
- 3+ years' experience in MS&T, Process Engineering, CQV, or Manufacturing Support within GMP environment.
- Experience with technology transfer, commissioning, qualification, and validation activities.
- Strong understanding of GMP, Annex 1, PIC/S, risk management, and change control.
- Experience with fill-finish operations, filling lines, and aseptic processing.
- Excellent stakeholder management, project coordination, and client-facing communication skills.
- Exceptional interpersonal skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels.
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