GMP Process Mechanic – Maintenance & Compliance

SGS Consulting; Philadelphia (Philadelphia County); On-site; USD 70,000 - 110,000; Full time

Job summary

SGS Consulting in Philadelphia is seeking an experienced Facilities Specialist to maintain pilot plant and R&D utilities, ensuring cGMP compliance and supporting plant systems. You will perform preventive and corrective maintenance, develop SOPs, and coordinate with contractors daily.

The role requires strong problem-solving, safety awareness, and the ability to work under deadlines in an FDA-regulated environment; weekend/on-call rotations may be required.

Qualifications

• Must have experience in a cGMP facilities department in FDA-regulated industry.
• Experience with 21 CFR Part 11 compliance and GMP documentation.
• Experience with FDA or regulatory inspections/audits.
• Proficiency with CMMS and MS Office tools.

Responsibilities

• Maintain GMP and non-GMP utilities for pilot plant and R&D facility.
• Perform preventive and corrective maintenance on process equipment.
• Maintain spare parts inventory for critical equipment.
• Schedule maintenance and work orders with user groups.
• Develop and adhere to SOPs and GMP documentation as required.
• Monitor outside contractors for maintenance/calibration activities.
• Participate in planning and process improvement at dept. and cross-functional level.
• Ensure operations meet cGMP and OSHA safety standards.
• Interact with Downstream/Upstream Ops, QA, QC, Validation, and others.
• Prepare reports with solutions to technical problems.
• Support plant systems (steam, WFI, cooling towers, etc.).

Skills

GMP plant operations

21 CFR Part 11

Regulatory inspections

CMMS proficiency

Problem solving

Cross-functional collaboration

Safety compliance

Education

High School Diploma

Associate’s degree or equivalent

5+ years in cGMP facilities (with Associate’s)

7+ years with High School Diploma

Tools

CMMS software

Microsoft Office

Job description

SGS Consulting in Philadelphia is seeking an experienced Facilities Specialist to maintain pilot plant and R&D utilities, ensuring cGMP compliance and supporting plant systems. You will perform preventive and corrective maintenance, develop SOPs, and coordinate with contractors daily.

The role requires strong problem-solving, safety awareness, and the ability to work under deadlines in an FDA-regulated environment; weekend/on-call rotations may be required.