The MST Engineer is responsible for leading the Manufacturing Science & Technology (MST) and Process Engineering functions within our mid-size sterile fill‑finish CDMO. This pivotal role drives technical excellence, process optimization, equipment qualification, and regulatory compliance across all manufacturing operations. The ideal candidate brings strong leadership capability, deep technical expertise in aseptic processing, and the ability to collaborate cross-functionally to ensure world-class manufacturing performance, reliable commercial supply, and continuous improvement. This position reports to the Director of Manufacturing or VP of Operations.
Key Responsibilities
- Act as our resident in-house SME for our Isolators and Automatic Filling lines
- Oversee process engineering for sterile finish operations, including process design, optimization, troubleshooting, and lifecycle management
- Ensure robust execution of equipment qualification activities (URS, DQ, IQ, OQ, PQ) and maintain documentation compliance
- Develop and implement manufacturing strategies for scale-up, process robustness, and yield improvement
- Lead process validation, cleaning validation, and continuous improvement initiatives
- Own change control strategy and ensure appropriate impact assessments for equipment, process, and utility modifications
- Support technology transfer activities for clinical and commercial products
- Collaborate with Quality, Manufacturing, and Regulatory Affairs to maintain audit readiness and drive compliance
- Manage engineering capital projects, timelines, budgets, and vendor interactions
- Drive operational excellence using Lean, Six Sigma, and structured problem-solving methodologies
- Communicate technical updates, risk assessments, and project status to leadership and key stakeholders
- Ensure equipment reliability through effective preventive maintenance, calibration, and lifecycle programs
Experience and Qualifications
- Minimum five (5) years of experience in pharmaceutical or biotechnology manufacturing within GMP-regulated environments
- Minimum 3 (three) years of experience with isolators, automated filling lines, and sterile utilities (WFI, clean steam, nitrogen, compressed air)
- Demonstrated expertise in process validation (IQ/OQ/PQ), equipment qualification, and FDA Process Validation Guidance implementation
- Strong working knowledge of FDA, EMA, ICH, and EU Annex 1/15 regulatory requirements
- Experience developing, coaching, and managing engineering teams (we see this role growing)
- Proficiency with engineering project management, equipment lifecycle management, and risk assessment tools (FMEA, HAZOP, QRM)
- Exceptional communication skills with the ability to present technical concepts to executive teams and external partners
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