Maintain facilities and process equipment supporting Commercial and Clinical manufacturing, Research and Development, and related services.
Manage staff to support 24/7 operations, ensuring safe, reliable, and cost-effective usage.
Coach, guide, and direct the facility team, monitoring and assessing performance of maintenance personnel and contractors.
Leverage prior GMP knowledge and experience to present to FDA or other regulatory agencies.
Collaborate with teams to identify and implement continuous improvement opportunities for systems and processes.
Specify and recommend equipment modifications to enhance safety, reliability, and operability.
Communicate regularly with customers, partners, and stakeholders to share key developments, opportunities, and risks.
Manage operating status and outages for systems, facilities, and utilities to maximize uptime.
Develop and implement corrective action plans for facility system repairs, replacements, and modifications.
Ensure timely completion of maintenance work orders.
Track facilities expenditures and prepare the annual budget.
Foster a culture of inclusion, prioritizing safety and injury prevention.
Maintain compliance by updating maintenance and operations SOPs for improved scheduling and equipment uptime.
Perform additional assigned duties as needed.
Primarily facility-based, involving oversight of manufacturing and R&D systems, with tasks including maintenance, inspections, and documentation.
Requires accessing small spaces to assess mechanical issues and standing or walking for extended periods.
Involves prolonged periods of computer use for tracking expenditures, preparing budgets, and updating SOPs.
May require lifting up to 50 pounds.
May involve after-hours responses and extended shifts to support facility operations.
Occasional travel may be required for regulatory presentations or vendor interactions.
High School Diploma/GED or local equivalent required; Bachelor’s degree in a relevant field preferred.
5-8 years of relevant maintenance experience required.
2-4 years of managerial experience in pharmaceuticals, biotech, food processing, high-tech, or other heavily regulated industries required.
2+ years of experience managing facilities under GMP regulatory compliance required.
Comprehensive knowledge of maintenance practices for equipment such as boilers, chillers, air handlers, HVAC systems, cooling towers, pure steam generators, Water for Injection systems, autoclaves, heat exchangers, security systems, electrical distribution, fire protection, clean-in-place systems, classified air systems, RODI systems, emergency generators, and fume exhaust systems.
Familiarity with pharmaceutical manufacturing equipment, including liquid filling machines, stoppering machines, capping machines, vial washers, and dehydrogenation ovens.
Ability to manage multiple responsibilities with strong self-motivation.
Capability to work independently and collaboratively in a team-oriented environment.
Trained in cGMP operations for pharmaceutical, biotechnology, or medical device manufacturing.
Knowledge of aseptic gowning and cleaning techniques.
Proficiency in managing after-hours responses and extended shifts to support planned or unplanned events.
Strong analytical, problem-solving, and communication skills.
Leadership skills to guide and coach teams effectively.
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