Process Mechanic
Share
Job Location:
Monthly Salary:
Experience Required:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Position: Process Mechanic
Location: Exton Pennsylvania
Work Type: On-site only (no hybrid/remote)
Shift: First Shift (7:00 AM 3:30 PM MondayFriday)
OnCall: Weekend rotation (1 weekend/month) occasional offhour emergencies
Environment: Cleanroom GMP Biologics Facility
Job Summary
The Process Mechanic is responsible for the operation monitoring preventive maintenance and repair of GMP and nonGMP utilities HVAC systems and processrelated equipment. This role supports a biologics cleanroom facility and requires strong understanding of cGMP standards technical troubleshooting and coordination with internal and external stakeholders.
Key Responsibilities
- Operate and maintain:
- Plant steam & clean steam systems
- Chilled water systems & cooling towers
- Compressed air systems
- WFI (Water for Injection) systems
- Plant steam & clean steam systems
- Perform corrective and preventive maintenance on process equipment
- Manage spare parts for critical systems
- Schedule and prioritize work orders with user groups
- Monitor and manage contractors performing maintenance & calibration
- Review technical results develop testing criteria and recommend solutions
- Ensure compliance with:
- cGMP regulations
- EMEA/JP guidelines
- OSHA & safety protocols
- FDA audit expectations
- cGMP regulations
- Participate in process improvement initiatives
- Maintain SOPs and GMP documentation
Qualifications
Required
- High School Diploma
- 7 years experience in a cGMP Facilities department (FDAregulated)OR
- Associate degree 5 years relevant cGMP experience
Preferred
- Experience with 21 CFR Part 11
- Familiarity with CMMS software
- Strong MS Office proficiency
- Demonstrated ability to troubleshoot under pressure
- Effective reasoning problemsolving & communication skills
Requirements
Physical Requirements
- Frequent standing walking climbing kneeling crouching balancing
- Ability to lift/move up to 50 lbs
- Handling laboratory equipment chemicals & biological materials
Work Schedule
- Onsite: MondayFriday 7:00 AM 3:30 PM
- OnCall: 1 weekend per month (Fri 11 PM to Sun 11 PM)
- Hours may vary based on business needs.
Required Skills:
HVAC Equipment FDA cGMP
Required Education:
High School Diploma7 years experience in a cGMP Facilities department (FDAregulated)ORAssociate degree 5 years relevant cGMP experience
Company Industry
IT Services and IT Consulting
Key Skills
- Mechanic Experience
- Diesel Engine Repair
- Mechanical Knowledge
- Air Brake
- Alignment
- Automotive Diagnostics
- Automotive Repair
- Maintenance
- Welding
- Hydraulics
- Equipment Repair
- Leadership Experience
