Process Mechanic
SGS Consulting
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.
Vacancy posted a month ago
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