Senior Manufacturing Engineering Lead, Associate Director

Biogen; North Carolina; On-site; USD 147,000 - 203,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life insurance

401(k) with company match

Tuition reimbursement

Employee stock purchase plan

Paid vacation and holidays

Job summary

Biogen is seeking a Manufacturing Engineering Lead to oversee a critical function within Site Engineering and Facilities. You will manage a team of engineers, drive validation programs, and ensure equipment reliability, safety, and regulatory compliance.

You will collaborate across Manufacturing, Quality, EHS, and global engineering teams to optimize processes, budgets, and capital projects while supporting 24/7 manufacturing operations.

Qualifications

• Bachelor’s degree in engineering from an accredited college or university.
• 10+ years of experience in biotechnology, pharmaceutical, or adjacent industry.
• 2+ years managing engineering professionals, contractors, or cross-functional teams.
• In-depth GMP validation, manufacturing, engineering, or facilities experience.
• Knowledge of biopharmaceutical manufacturing operations, cGMP, GLP, ISO requirements.
• Experience with FDA or regulatory interactions and corrective actions.

Responsibilities

• Lead and develop the Manufacturing Engineering function with a team of ~7–15 engineers.
• Ensure reliability, performance, safety, and compliance of equipment and systems.
• Set departmental goals, metrics, and priorities aligned with site objectives.
• Represent Site Engineering and Facilities in leadership discussions on strategy and risk.
• Lead validation strategy, lifecycle management, and QA alignment.
• Present programs during regulatory audits and inspections.
• Develop capital forecasts and manage the site’s capital portfolio.
• Drive continuous improvement to improve reliability and efficiency.
• Provide technical direction during critical equipment issues for uninterrupted operations.
• Collaborate with Quality and EHS to maintain safe, validated equipment state.
• Support 24/7 manufacturing as needed.
• Coach and develop engineering staff.

Skills

Engineering leadership

GMP validation

Regulatory interactions

Cross-functional leadership

Budget management

Education

Bachelor’s degree in engineering

Tools

Distributed control systems

Programmable logic controllers

P&IDs

SOPs

Job description

Biogen is seeking a Manufacturing Engineering Lead to oversee a critical function within Site Engineering and Facilities. You will manage a team of engineers, drive validation programs, and ensure equipment reliability, safety, and regulatory compliance.

You will collaborate across Manufacturing, Quality, EHS, and global engineering teams to optimize processes, budgets, and capital projects while supporting 24/7 manufacturing operations.