Mgr, Engineering-Facilities Utility
Alkermes
July 01, 2026
On-site
Cincinnati Metropolitan Area
Operations
Responsibilities:
- Ensure engineering department resources meet site tactical and strategic needs.
- Develop and implement process and reliability improvement projects.
- Oversee relationships with key vendors, A&E firms, and engineering service providers.
- Apply good project management practices within the department.
- Support maintenance and manufacturing with system operation, preventive maintenance, and specification/procurement of replacement equipment, spare parts, and supplies.
- Provide customer service and ensure interdepartmental teamwork to meet site objectives.
- Develop staff through technological understanding, cross-training, and problem-solving; provide coaching/feedback and set performance standards.
- Stay current on industry/engineering standards and trends.
- Ensure activities meet regulatory standards (e.g., FDA, MHRA, OSHA, EPA).
- Monitor facility/utility operational robustness; identify, scope, estimate, and manage system improvement/OE projects.
- Assist MFG/RS/ES groups with deviations and investigations.
- Oversee development of SOPs for equipment and systems; write/review/approve design and C&Q documents.
- Develop, conduct, and document test methods for utility troubleshooting, commissioning, and validation.
- Participate in integrating new technology/manufacturing innovations/new products supporting business goals.
Skills/Abilities:
- Strong mechanical/chemical engineering knowledge for facility and drug product systems.
- Knowledge of electrical/electronic/instrumentation systems; computer systems/software.
- In-depth CGMP, OSHA, EPA, and FDA facility requirements.
- Knowledge of chemistry, statistics, facility design, cost estimation, process control, and scale-up.
- Knowledge of pharmaceutical operations and equipment validations; ability to specify/size equipment.
- Strong communication, documentation, and writing skills (protocols, reports, specs, SOPs); hands-on troubleshooting/installation; troubleshooting/maintenance of facility/utility equipment.
- People skills to supervise and collaborate; strong project management.
Personal Attributes:
- Customer service orientation; strong technical communication; organizational skills; positive management attitude; self-management and prioritization; ability to supervise/motivate diverse personnel; fast problem-solving; collaborative influence/negotiation.
Education:
- BS in Engineering required.
Experience:
- Minimum 10 years pharmaceutical production experience, including 6 years supervisory experience; ability to motivate exempt/non-exempt employees; thorough cGMP knowledge.
- Experience required in machine design, computer systems/instrumentation, validations, electrical power, and facility design/construction.
- Preferred: experience plus cost analysis and pharmaceutical manufacturing validation.
Application instructions:
- Not specified in the provided text.
- Ensure engineering department resources meet site tactical and strategic needs.
- Develop and implement process and reliability improvement projects.
- Oversee relationships with key vendors, A&E firms, and engineering service providers.
- Apply good project management practices within the department.
- Support maintenance and manufacturing with system operation, preventive maintenance, and specification/procurement of replacement equipment, spare parts, and supplies.
- Provide customer service and ensure interdepartmental teamwork to meet site objectives.
- Develop staff through technological understanding, cross-training, and problem-solving; provide coaching/feedback and set performance standards.
- Stay current on industry/engineering standards and trends.
- Ensure activities meet regulatory standards (e.g., FDA, MHRA, OSHA, EPA).
- Monitor facility/utility operational robustness; identify, scope, estimate, and manage system improvement/OE projects.
- Assist MFG/RS/ES groups with deviations and investigations.
- Oversee development of SOPs for equipment and systems; write/review/approve design and C&Q documents.
- Develop, conduct, and document test methods for utility troubleshooting, commissioning, and validation.
- Participate in integrating new technology/manufacturing innovations/new products supporting business goals.
Skills/Abilities:
- Strong mechanical/chemical engineering knowledge for facility and drug product systems.
- Knowledge of electrical/electronic/instrumentation systems; computer systems/software.
- In-depth CGMP, OSHA, EPA, and FDA facility requirements.
- Knowledge of chemistry, statistics, facility design, cost estimation, process control, and scale-up.
- Knowledge of pharmaceutical operations and equipment validations; ability to specify/size equipment.
- Strong communication, documentation, and writing skills (protocols, reports, specs, SOPs); hands-on troubleshooting/installation; troubleshooting/maintenance of facility/utility equipment.
- People skills to supervise and collaborate; strong project management.
Personal Attributes:
- Customer service orientation; strong technical communication; organizational skills; positive management attitude; self-management and prioritization; ability to supervise/motivate diverse personnel; fast problem-solving; collaborative influence/negotiation.
Education:
- BS in Engineering required.
Experience:
- Minimum 10 years pharmaceutical production experience, including 6 years supervisory experience; ability to motivate exempt/non-exempt employees; thorough cGMP knowledge.
- Experience required in machine design, computer systems/instrumentation, validations, electrical power, and facility design/construction.
- Preferred: experience plus cost analysis and pharmaceutical manufacturing validation.
Application instructions:
- Not specified in the provided text.