We are seeking an experienced engineering leader to oversee facility infrastructure, utilities, manufacturing equipment, and engineering support within a regulated pharmaceutical manufacturing environment. This position will lead internal engineering resources and external technical partners while ensuring site systems operate safely, reliably, and in compliance with applicable quality and regulatory requirements. The role combines people leadership, technical problem solving, capital project execution, reliability improvement, and day-to-day support of manufacturing operations.
Key Responsibilities:
- Lead engineering support for facility systems, utilities, production equipment, and site infrastructure.
- Establish priorities based on operational needs, reliability, capacity, and long-term business objectives.
- Identify and implement equipment, process, and reliability improvement opportunities.
- Direct internal engineers, contractors, consultants, and engineering service providers.
- Apply strong project management practices to capital and engineering initiatives.
- Partner with Maintenance and Manufacturing to resolve equipment issues and improve system performance.
- Support equipment specifications, replacements, spare-parts strategies, and procurement decisions.
- Promote collaboration across Engineering, Operations, Quality, Maintenance, Technical Services, and other site groups.
- Develop team capabilities through coaching, cross-training, technical development, and structured problem solving.
- Ensure engineering activities comply with cGMP, safety, environmental, and regulatory requirements.
- Monitor the condition and reliability of critical facility and utility systems and develop improvement plans.
- Define project scope, cost, schedule, and technical requirements and manage projects through completion.
- Support deviations, investigations, root-cause analysis, and corrective actions related to equipment and facility systems.
- Review and approve engineering specifications, design documents, procedures, and commissioning and qualification documentation.
- Develop and execute testing for troubleshooting, commissioning, qualification, and validation activities.
- Support the introduction of new technologies, equipment manufacturing improvements, and new product requirements.
Leadership & Business Responsibilities:
- Develop departmental goals, priorities, and performance measures.
- Manage engineering resources to support both operational and strategic needs.
- Communicate project status, technical risks, performance, and operating conditions to site leadership.
- Support capital planning, departmental budgets, project estimates, and expense management.
- Monitor spending and approve engineering purchases within assigned authority.
- Support regulatory inspections and audits involving facilities, utilities, equipment, engineering documentation, or validation.
- Participate in recruiting, interviewing, and developing engineering personnel.
Technical Knowledge - Strong working knowledge of:
- Pharmaceutical manufacturing facilities and operations
- Plant and clean utility systems
- Mechanical, chemical, and process engineering fundamentals
- Electrical, instrumentation, controls, and automation systems
- Computerized manufacturing and facility systems
- Equipment and utility commissioning, qualification, and validation
- Preventive maintenance and reliability practices
- Equipment sizing, troubleshooting, and specification
- Facility design, construction, and cost estimation
- Process controls, change control, and controlled documentation
- cGMP requirements and regulated manufacturing practices
Qualifications:
- Bachelor's degree in Engineering required.
- 10+ years of pharmaceutical manufacturing, engineering, or production experience.
- 6+ years of supervisory or technical leadership experience.
- Strong knowledge of cGMP requirements and regulated pharmaceutical operations.
- Experience with facility systems, utilities, manufacturing equipment, and infrastructure.
- Background in equipment design, instrumentation, computerized systems, electrical systems, validation, and facility engineering.
- Experience supporting capital projects, facility upgrades, design, and construction.
- Strong technical problem-solving, documentation, and communication skills.
- Experience preparing or reviewing engineering specifications, protocols, technical reports, and procedures.
- Knowledge of change control and documentation control practices.
- Experience with pharmaceutical equipment and facility qualification or validation.
- Cost estimating, capital planning, or financial analysis experience preferred.
Leadership Profile:
- Strong people leadership and team development skills
- Effective communication across technical and operational groups
- Strong organization and prioritization
- Technical troubleshooting and decision-making ability
- Ability to manage multiple projects and competing priorities
- Strong customer service and cross-functional collaboration
- Ability to influence teams and drive issues through resolution
- Strong project management and documentation skill