Associate Director, Manufacturing Engineering Lead - Downstream

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

Benefits offered by this job

Medical, Dental, Vision Insurance

Fitness & Wellness programs

Paid vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. seeks an experienced Manufacturing Engineering Lead to guide a 7–15 person team and own the validation, reliability, and optimization of manufacturing process equipment and warehouse technologies.

You will partner with Manufacturing, Quality, EHS, and global teams to drive safe, compliant operations. You will set strategic goals, manage budgets, and lead continuous-improvement initiatives across site operations, while supporting 24/7 manufacturing as needed and mentoring engineering

Qualifications

• Bachelor's degree in engineering is required.
• At least 10 years in biotechnology, pharmaceutical, or related fields.
• Minimum 2 years leading engineering professionals or cross-functional teams.
• Deep experience with GMP validation, manufacturing, engineering or facilities.
• Knowledge of biopharma manufacturing operations, cGMP, GLP, ISO requirements.
• Experience with FDA or regulatory investigations and corrective actions.
• Experience leading GMP validation activities and compliant manufacturing systems.
• Experience with large budgets and complex engineering projects.
• Ability to lead cross-site or cross-functional initiatives.

Responsibilities

• Lead and develop the Manufacturing Engineering function (7–15 staff).
• Ensure reliability, performance, safety, and compliance of equipment and systems.
• Set departmental goals, metrics, and priorities aligned to site objectives.
• Represent engineering in leadership discussions on manufacturing strategy and risks.
• Lead validation strategy, execution, and lifecycle management with QMS alignment.
• Present and defend programs during regulatory audits and inspections.
• Forecast operating and capital needs; oversee the site small-capital portfolio.
• Drive continuous-improvement, upgrades, and reliability enhancements.
• Provide technical direction during critical equipment issues.
• Collaborate with Quality and EHS to maintain validated state.
• Support 24/7 manufacturing operations as needed.
• Coach and develop engineers, promoting accountability and delegation.

Skills

Engineering Leadership

Biopharma Manufacturing

GMP Validation

Regulatory Liaison

Cross-functional Leadership

Education

Bachelor's in Engineering

Job description

About this role

The Manufacturing Engineering Lead manages a mission-critical function within Site Engineering and Facilities, overseeing the installation, validation, reliability, and optimization of manufacturing process equipment and cGxP warehouse technologies. This leader will guide a team of engineers, represent Site Engineering and Facilities in key operational decisions, and partner closely with Manufacturing, Quality, EHS, Maintenance, Automation, and global engineering teams. The role requires a strong technical foundation in biopharmaceutical manufacturing, validation, equipment performance, and regulated operations.

What you’ll do

• Lead and develop the Manufacturing Engineering function, including a team of approximately 7–15 employees.
• Ensure the 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.

Who you are

You are an experienced engineering leader who combines deep technical knowledge with sound operational judgment. You can lead through complex equipment and compliance challenges, develop engineering talent, influence senior stakeholders, and make timely decisions in a fast-paced manufacturing environment.

Required skills

• Bachelor’s degree in engineering from an accredited college or university
• At minimum, 10 years of relevant experience in biotechnology, pharmaceutical, or adjacent industry
• At minimum, 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, EMEA, and 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

Preferred skills

• Working knowledge of distributed control systems, programmable logic controllers, P&IDs, and standard operating procedures
• Experience with manufacturing process equipment and supporting utility or facility systems
• Lean Six Sigma, continuous-improvement, or operational-excellence experience
• Contract management and contractor safety-management experience
• Experience supporting large-scale, multi-use manufacturing facilities
• Strong business acumen, strategic planning, capital-investment analysis, and resource-management capabilities
• Ability to communicate engineering strategy and technical risk effectively to senior leaders, regulators, vendors, and cross-functional partners

Job Level

Management

Additional Information

The base compensation range for this role is: $147,000.00-$202,500.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.