Responsibilities:
- Provide leadership, strategy, and tactical direction for engineering and maintenance teams supporting assembly and packaging lines in 24/7 operation.
- Ensure safety of all personnel during plant operations and engineering activities.
- Ensure staff are trained and comply with GMP standards and procedures.
- Maximize staff productivity and efficient use of resources.
- Maintain and improve plant capability and equipment reliability; support capital project investment.
- Identify improvements, analyze, recommend solutions, sponsor and implement improvement projects.
- Maintain/develop KPIs; supervise, assess, and develop staff; ensure targets and milestones are met on time and on budget.
- Interface with internal stakeholders (clients, Facilities & Engineering leadership, Engineering Technical Authority, Technology, Global Capital Project Management, EHS, Process Development).
- Oversee a safe and compliant workforce; provide day-to-day, small project, and plant shut-down support.
- Support GMP product development in a highly regulated environment.
- Manage partners and drive business/process improvements.
- Ensure readiness/compliance for internal audits, external agency audits, and partner visits.
- Present engineering plans/status; review/approve engineering designs and equipment changes.
- Perform administrative/oversight for proposals and expenditures; develop expenditure requests and partner on engineering solutions.
- Troubleshoot to reduce downtime; drive equipment reliability.
Qualifications:
- Basic: Doctorate + 4 years; OR Masterโs + 8 years; OR Bachelorโs + 10 years in Manufacturing, Packaging, or Quality (pharma/medical device/biotech).
- 4+ years directly managing people and/or leading teams/projects/programs and/or directing resource allocation.
Preferred:
- 12+ years relevant work; 8+ years in operations/manufacturing.
- 10+ years in regulated environments (FDA/cGMP, OSHA, EPA) and lead engineering in regulated GMP.
- Knowledge of GMP manufacturing equipment (design/operations); strong organizational/administrative leadership.
- Excellent verbal/written communication; collaborate cross-functionally; mentor/lead; understand regulatory trends; experience managing multiple resource demands and prioritization.