Process Mechanic
Exton, PA
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: Joulé
Job ID: 345714
Date Posted: 03/10/2026
Shortcut: http://jobs.systemone.com/8eTcO2
Job Title: Process Mechanic
Location: Exton, PA
Type: Contract
Overview
The Process Mechanic is responsible for monitoring, operation, performing preventive maintenance and corrective maintenance of GMP and non-GMP utilities and HVAC equipment as well as process related equipment.
Responsibilities
- Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
- Perform preventive and corrective maintenance on process related equipment. Maintains spare parts inventory for critical equipment.
- Schedule preventive maintenance and corrective work orders working with user groups.
- Develop and adhere to all SOPs and other GMP documentation as required.
- Monitor activities of outside contractors supporting maintenance and calibration activities.
- Participate in planning and process improvement activities at the departmental and inter-functional level.
- Ensure adherence of operations to cGMP as well as industry safety standards and OSHA guidelines.
- Interact cross-functionally with Downstream/Upstream Operations, Support Operations, Quality Assurance, Quality Control, Validation, and other internal and external functions and the R&D Facility.
- System operation includes, but is not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical grade water systems (WFI water) equipment under GMP operation.
- Analyzes results and may develop testing and maintenance specification on new and existing equipment.
- Prepare reports with recommendations for solutions to technical problems.
- High School Diploma required, Associates Degree or equivalent experience preferred.
- A minimum of 5 years working experience in a cGMP Facilities department in a FDA-regulated industry with Associates Degree, or a minimum of 7 years working experience in a cGMP Facilities department in a FDA-regulated industry with High School Diploma.
- Prior experience in a GMP plant and experience with 21 CFR Part 11.
- Knowledge of cGMP/EMEA and JP regulations.
- Experience with inspections/audits by the FDA or other similar regulatory agencies.
- Experience with CMMS software.
- Working knowledge of Microsoft operating systems and proficiency in MS Office applications.
- Ability to prioritize and successfully manage complex and competing projects.
- Demonstrated ability to deliver effective troubleshooting solutions under tight timelines and delivery pressures while maintaining composure and strong performance.
- Limited handling of laboratory equipment, chemicals, and biological materials
- This position will require weekend on-call rotation and some off-hour emergency response.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan
Ref: #558-Scientific
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