Process Mechanic

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

Job 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.
• Maintain 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.
• Prepare reports with recommendations for solutions to technical problems.
• Support plant systems including steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical-grade water systems (WFI).

Skills

• Experience in GMP plant operations and compliance with 21 CFR Part 11.
• Knowledge of cGMP/EMEA and JP regulations.
• Experience with inspections/audits by FDA or similar regulatory agencies.
• Proficiency in CMMS software and Microsoft Office applications.
• Strong troubleshooting, problem-solving, and reasoning skills.
• Ability to prioritize and manage complex and competing projects.
• Effective interpersonal, written, and oral communication skills.
• Ability to work under tight timelines and delivery pressures while maintaining composure.

Education/Experience

• High School Diploma required; Associate’s degree or equivalent experience preferred.
• Minimum of 5 years working experience in a cGMP Facilities department in an FDA-regulated industry with Associate’s degree, or minimum of 7 years working experience with High School Diploma.
• Prior experience in a GMP plant environment.

Physical Requirements

• Frequent standing, walking, use of hands, reaching, climbing, balancing, stooping, kneeling, crouching, or crawling.
• Occasional sitting.
• Must frequently lift and/or move up to 50 pounds.
• Limited handling of laboratory equipment, chemicals, and biological materials.
• This position requires weekend on-call rotation and some off-hour emergency response.