Associate Director, Manufacturing Engineering Lead - Downstream

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation

Job summary

Biogen is seeking an experienced Manufacturing Engineering Lead in the United States to oversee the installation, validation, reliability and optimization of manufacturing process equipment and cGxP warehouse technologies. You will guide a team of engineers, partner with Quality, EHS and cross-functional groups, and drive continuous improvement in a regulated biopharmaceutical environment.

The role requires deep technical knowledge in biopharmaceutical manufacturing, validation, and equipment

Qualifications

• Bachelor's degree in engineering; 10+ years in biotech/pharma or adjacent industry.
• Experience leading engineering professionals, contractors, or cross-functional teams for 2+ years.
• Deep GMP validation and manufacturing/Facilities knowledge; familiarity with biopharma operations.
• Experience with FDA or regulatory investigations and corrective actions; GMP validation leadership.

Responsibilities

• Lead and develop the Manufacturing Engineering function with a team of 7–15 employees.
• Ensure reliability, safety, compliance of manufacturing equipment and systems.
• Set departmental goals, metrics, and operating priorities aligned with site objectives.
• Represent Site Engineering & Facilities in leadership discussions on strategy and risks.
• Lead validation strategy, execution, and lifecycle management per QMS and global procedures.
• Present and defend programs during regulatory audits and inspections.
• Manage budgets, resources, and capital portfolio; drive continuous improvement.
• Provide technical direction during critical equipment issues to sustain operations.

Skills

Engineering degree

10+ years biotech/pharma

2+ years leadership

GMP validation

GxP knowledge

FDA regulatory interaction

Budget & project management

Cross-site initiatives

Education

Bachelors in Engineering

Tools

DCS

PLC

P&IDs

SOPs

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-$202,500.00Base 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.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participation

Why 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.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 onto learn more about our Biogen.

Equal Opportunity Employment

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.VEVRAA Federal Contractor.We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.PDN-a3281276-7495-4e83-9667-83f9b27a0964