GMP Facilities Mechanic; Onsite-Bridgewater, NJ

GMP Senior Facilities Mechanic

For the past 25 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

We are seeking an innovative and highly motivated GMP Senior Facilities Mechanic who will contribute significantly to the success of service maintenance, repair, and supporting the client in Bridgewater, NJ Facility and associated equipment.

The primary focus of this position will be to perform preventative maintenance, repairs, calibration, and troubleshooting of GMP process equipment along with Utility and Facility equipment. This is a hands-on position that is local to the Bridgewater, NJ facility.

Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle challenges as the company grows.

Responsibilities:

• Perform routine maintenance and troubleshooting and other process equipment in a cell therapy manufacturing facility in a Good Manufacturing Practice (GMP) environment
• Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
• Perform equipment calibrations and support validation testing to meet quality and regulatory requirements
• Respond promptly to equipment failures and implement corrective actions to minimize downtime. Provide on-call support as required
• Execute preventative maintenance activities to ensure optimal functionality of manufacturing equipment
• Support installing and qualifying new equipment, ensuring adherence to GMP guidelines
• Support facilities team in providing maintenance and repair in the GMP environment as needed
• Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized Maintenance Management System (CMMS)
• Execute alarm response and proficiency in Building Maintenance Systems and Environmental Monitoring Systems.
• Manage parts, order, and coordinate with equipment vendors and area owners to schedule maintenance activities
• Maintain tools and test equipment and ensure they are properly calibrated and in good safe working condition
• Collaborate with manufacturing and quality control teams to address technical issues and optimize processes.
• Support Quality Change Controls and CAPA investigations.
• Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
• Participate in training programs to enhance technical skills and knowledge
• Experience with HVAC, RTUs, Split Systems, LP Boilers, Air Compressors/dryers, Process Gas Distribution, Process Lab equipment (BSCs, Incubators, FZRs, REFs, Cryo Storage, Centrifuges, Pumps, Vacuum Skids, and backflow prev enters is a plus

Requirements:

• Associate degree or equivalent in engineering or a related field with five plus years of experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals.
• Strong understanding of GMP regulations and quality standards.
• Proficient in troubleshooting and repairing complex manufacturing equipment.
• Ability to read and understand technical documents and engineering drawings.
• Excellent organizational and documentation skills.
• Ability to work collaboratively in a team-oriented environment.
• Effective communication skills to interact with diverse stakeholders.
• Detail-oriented with a commitment to maintaining high-quality standards.
• Ability to lift and carry up to 50 lbs.

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