Assoc Director, Manufacturing Engineering Lead - Downstream
About The Position
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. The role leads a team of engineers, represents Site Engineering and Facilities in operational decisions, and partners with Manufacturing, Quality, EHS, Maintenance, Automation, and global engineering teams. It requires technical expertise in biopharmaceutical manufacturing, validation, equipment performance, and regulated operations. The leader establishes departmental goals, development plans, metrics, and priorities; leads validation strategy and lifecycle management; supports regulatory inspections; oversees operating and capital forecasts and the site’s small-capital portfolio; and guides continuous improvement and equipment reliability initiatives. The position supports 24/7 manufacturing operations as business needs require and develops engineering employees through coaching, technical development, accountability, and delegation.
Requirements
- Bachelor’s degree in engineering from an accredited college or university.
- At least 10 years of relevant experience in biotechnology, pharmaceutical, or an adjacent industry.
- At least 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.
Nice To Haves
- 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.
Responsibilities
- Lead and develop the Manufacturing Engineering function, including a team of approximately 7–15 employees.
- Ensure the 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 about manufacturing strategy, technical risks, and operational direction.
- Lead validation strategy, execution, and lifecycle management in 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 oversee the site’s small-capital portfolio.
- Prioritize continuous-improvement initiatives, equipment upgrades, and engineering solutions to 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, promoting technical capability, accountability, and effective delegation.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness and wellness programs, including fitness reimbursement
- Short- and long-term disability insurance
- At least 15 days of paid vacation
- Additional end-of-year shutdown time off (December 26–31)
- Up to 12 company-paid holidays
- Three paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid maternity and parental leave
- 401(k) program with company-matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term cash bonus and long-term equity incentive opportunities for eligible regular employees
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What This Job Offers
Job Type
Full-time
Career Level
Manager
