Engineering Manager

Overview of this Position

The Engineering Manager 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.

Non‑Negotiable Requirements

• Minimum eight (8) years of experience in pharmaceutical or biotechnology manufacturing within GMP-regulated environments
• Minimum five (5) years in technical leadership or engineering management role
• Proven hands-on experience in sterile fill‑finish operations, aseptic processing, isolators/RABS, or parenteral manufacturing
• 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
• 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

Preferred Requirements

• Bachelor’s degree in engineering (Chemical, Mechanical, Industrial, or related field); Master’s degree preferred
• Experience working in a CDMO or multi‑product aseptic manufacturing environment
• Lean/Six Sigma certification (Green Belt or Black Belt)
• Experience supporting product commercialization and technology transfer
• Familiarity with lyophilization, isolators, automated filling lines, and sterile utilities (WFI, clean steam, nitrogen, compressed air)

Responsibilities Include

• Lead, mentor, and develop a team of MST and Process Engineering professionals
• 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

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office or manufacturing-controlled environment. Physical or environmental requirements will be addressed through the reasonable accommodation process.

We are an Equal Opportunity Employer committed to building a diverse and inclusive workforce. We welcome applications from all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other legally protected characteristic.