{"id":3838743,"url":"https://alion.io/job/biogen-associate-director-manufacturing-engineering-lead-downstream","title":"Associate Director, Manufacturing Engineering Lead - Downstream","company":{"id":449685,"name":"Biogen","domain":"biogen.com","url":"https://alion.io/company/biogen-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":21,"ghost_share":0,"stale_share":0.762,"repost_share":0.048,"time_to_fill_p50_days":36,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Research Triangle Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":147000,"max":202500,"currency":"USD","period":"year","gross":null,"usd_annual":202500},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-05T21:55:57Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-09T22:10:58Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"About this role\nThe 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.\nWhat you’ll do\nLead and develop the Manufacturing Engineering function, including a team of approximately 7-15 employees.\nEnsure the ongoing reliability, performance, safety, and compliance of manufacturing process equipment and assigned systems.\nEstablish departmental goals, development plans, operating metrics, and tactical priorities aligned with manufacturing and site objectives.\nRepresent Site Engineering and Facilities in site and factory leadership discussions involving manufacturing strategy, technical risks, and operational direction.\nLead validation strategy, execution, and lifecycle management while ensuring alignment with the Quality Management System and global procedures.\nPresent and defend manufacturing engineering and validation programs during regulatory audits and inspections.\nDevelop operating and capital forecasts, manage departmental resources, and provide oversight of the site’s small-capital portfolio.\nPrioritize continuous-improvement initiatives, equipment upgrades, and engineering solutions that improve reliability, efficiency, and manufacturing performance.\nProvide technical direction during critical equipment issues and support uninterrupted manufacturing operations.\nCollaborate with Quality and EHS to maintain equipment and systems in a safe, compliant, and validated state.\nSupport 24/7 manufacturing operations as business needs require.\nCoach and develop engineering employees while promoting technical capability, accountability, and effective delegation. \nWho you are\nYou 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.\nRequired skills\nBachelor’s degree in engineering from an accredited college or university\nAt minimum, 10 years of relevant experience in biotechnology, pharmaceutical, or adjacent industry.\nAt minimum, 2 years of experience managing or leading engineering professionals, contractors, or cross-functional technical teams.\nIn-depth experience with GMP validation, manufacturing, engineering, or facilities.\nDemonstrated knowledge of biopharmaceutical manufacturing operations, cGMP, GLP, EMEA, and ISO requirements.\nExperience working with FDA or comparable regulatory investigators, preparing responses to observations, and implementing corrective measures.\nExperience leading GMP validation activities and maintaining manufacturing systems in a compliant and validated state.\nExperience with large operating and capital budgets and complex engineering projects.\nDemonstrated ability to lead cross-site or cross-functional initiatives.\nPreferred skills\nWorking knowledge of distributed control systems, programmable logic controllers, P&IDs, and standard operating procedures.\nExperience with manufacturing process equipment and supporting utility or facility systems.\nLean Six Sigma, continuous-improvement, or operational-excellence experience.\nContract management and contractor safety-management experience.\nExperience supporting large-scale, multi-use manufacturing facilities.\nStrong business acumen, strategic planning, capital-investment analysis, and resource-management capabilities.\nAbility to communicate engineering strategy and technical risk effectively to senior leaders, regulators, vendors, and cross-functional partners.\nJob Level: Management Additional Information\nThe 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.\nRegular 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.\nIn 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:\nMedical, Dental, Vision, & Life insurances\nFitness & Wellness programs including a fitness reimbursement \nShort- and Long-Term Disability insurance\nA minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)\nUp to 12 company paid holidays + 3 paid days off for Personal Significance \n80 hours of sick time per calendar year\nPaid Maternity and Parental Leave benefit \n401(k) program participation with company matched contributions\nEmployee stock purchase plan \nTuition reimbursement of up to $10,000 per calendar year \nEmployee Resource Groups participation\nWhy Biogen?\nWe 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.\nAt 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.\nAll 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. 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