Process Mechanic

SGS_JOB_3401

Engineering
 Pennsylvania
GMP Utilities Maintenance
HVAC Systems
Preventive & Corrective Maintenance
CMMS Software
cGMP Compliance
Troubleshooting
SOP Documentation
OSHA & Safety Standards

Contract - 01 Year + (Highest possibilities of extension)

Location (mandatory): Exton, PA 19341 Under general direction, the Maintenance 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. The role supports pilot plant and R&D facilities and requires working in a fast-paced, highly technical environment with weekend on-call rotation and off-hour emergency response.

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.

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