Job Purpose:

Senior Manager of Engineering to lead and oversee engineering activities across drug development and manufacturing operations. This role will be responsible for driving capital projects, ensuring compliance with GMP regulations, optimizing manufacturing processes, and supporting the scale-up of drug products from development through commercial production. The ideal candidate has a strong background in pharmaceutical engineering, cross-functional leadership, and regulatory compliance within a GMP environment.

Essential Duties and Responsibilities:

• Lead and manage engineering teams supporting pharmaceutical process development, technology transfer, and commercial manufacturing.
• Oversee the design, installation, commissioning, and qualification (CQV) of equipment, utilities, and facilities used in drug development and production.
• Drive capital projects, including budgeting, scheduling, and vendor management.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs teams to ensure seamless tech transfer and process scale-up.
• Ensure all engineering systems and practices comply with cGMP, FDA, EMA, and other applicable regulatory standards.
• Lead root cause investigations, CAPA implementation, and continuous improvement initiatives.
• Manage preventive and corrective maintenance programs to ensure equipment reliability and performance.
• Support audits and inspections by regulatory authorities and customers.
• Mentor and develop a high-performing engineering team.
• Implement and monitor KPIs to track engineering performance and project progress.

Required Qualifications:

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related field.
• 8+ years of engineering experience in pharmaceutical, biotech, or related GMP-regulated industry, with 3+ years in a leadership or management role.
• Deep knowledge of GMP regulations, validation, and engineering documentation practices.
• Strong experience with process scale-up, tech transfer, and equipment qualification.
• Proven ability to lead cross-functional teams and manage multiple complex projects.
• Excellent problem-solving, communication, and stakeholder management skills.

Preferred Qualifications:

• Experience with sterile or aseptic manufacturing, biologics, or advanced therapies (e.g., cell and gene therapy).
• Familiarity with automation systems, MES, and digital manufacturing tools.
• PMP or Lean Six Sigma certification.
• Experience in facility design and expansion projects.

Working Conditions / Physical Requirements:

• This position requires lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.