Manufacturing Engineering Lead - Associate Director

NCBioImpact; Durham (NC); On-site; USD 147,000 - 203,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Fitness & Wellness programs including,

Short-and Long-Term Disability

Paid vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Durham, NC seeks a Manufacturing Engineering Lead to guide a team of 7–15 engineers, ensuring reliability, safety, and compliance of manufacturing equipment and cGMP warehouse systems.

You will drive validation strategy, lead audits with Quality/EHS, manage operating and capital budgets, and collaborate with cross‑functional partners across sites to optimize manufacturing performance. The role requires a strong biopharma background and GMP expertise.

Qualifications

• Bachelor’s degree in engineering from an accredited college.
• 10+ years of relevant experience in biotechnology, pharmaceutical, or adjacent industry.
• 2+ years of experience managing or leading engineering professionals, contractors, or cross-functional technical teams.
• In-depth experience with GMP validation, manufacturing, engineering, or facilities.
• Demonstrated knowledge of biopharmaceutical manufacturing operations, cGMP, GLP, ISO requirements.
• Experience working with FDA or comparable regulatory investigators, preparing responses to observations, and implementing corrective measures.
• Experience leading GMP validation activities and maintaining manufacturing systems in a compliant and validated state.
• Experience with large operating and capital budgets and complex engineering projects.
• Demonstrated ability to lead cross-site or cross-functional initiatives.

Responsibilities

• Lead and develop the Manufacturing Engineering function, including a team of approximately 7-15 employees.
• Ensure ongoing reliability, performance, safety, and compliance of manufacturing process equipment and assigned systems.
• Establish departmental goals, development plans, operating metrics, and tactical priorities aligned with manufacturing and site objectives.
• Represent Site Engineering and Facilities in site and factory leadership discussions involving manufacturing strategy, technical risks, and operational direction.
• Lead validation strategy, execution, and lifecycle management while ensuring alignment with the Quality Management System and global procedures.
• Present and defend manufacturing engineering and validation programs during regulatory audits and inspections.
• Develop operating and capital forecasts, manage departmental resources, and provide oversight of the site’s small-capital portfolio.
• Prioritize continuous-improvement initiatives, equipment upgrades, and engineering solutions that improve reliability, efficiency, and manufacturing performance.
• Provide technical direction during critical equipment issues and support uninterrupted manufacturing operations.
• Collaborate with Quality and EHS to maintain equipment and systems in a safe, compliant, and validated state.
• Support 24/7 manufacturing operations as business needs require.
• Coach and develop engineering employees while promoting technical capability, accountability, and effective delegation.

Skills

Engineering leadership

GMP validation

Biopharma manufacturing

Regulatory audits

Cross-functional collaboration

Budget management

Equipment reliability

Validation strategy

Education

Bachelor’s degree in engineering

Tools

Distributed control systems

Programmable logic controllers

P&IDs

Job description

Biogen in Durham, NC seeks a Manufacturing Engineering Lead to guide a team of 7–15 engineers, ensuring reliability, safety, and compliance of manufacturing equipment and cGMP warehouse systems.

You will drive validation strategy, lead audits with Quality/EHS, manage operating and capital budgets, and collaborate with cross‑functional partners across sites to optimize manufacturing performance. The role requires a strong biopharma background and GMP expertise.