Process Mechanic

Under general direction, the Process Mechanic/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.

System operation includes, but is not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical grade water systems (WFI water) equipment under GMP operation.

Analyzes results and may develop testing and maintenance specification on new and existing equipment.

Prepare reports with recommendations for solutions to technical problems.

The ability to function in a fast-paced, highly-technical environment and communicate effectively is essential to success.

• Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
• Perform preventive and corrective maintenance on process related equipment.
• Maintains 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 and the R&D Facility.

• High School Diploma required, Associates Degree or equivalent experience preferred.
• A minimum of 5 years working experience in a cGMP Facilities department in a FDA-regulated industry with Associates Degree, or a minimum of 7 years working experience in a cGMP Facilities department in a FDA-regulated industry with High School Diploma.
• Prior experience in a GMP plant and experience with 21 CFR Part 11.
• Knowledge of cGMP/EMEA and JP regulations.
• Experience with inspections/audits by the FDA or other similar regulatory agencies.
• Experience with CMMS software.
• Working knowledge of Microsoft operating systems and proficiency in MS Office applications.
• Ability to prioritize and successfully manage complex and competing projects.
• Effective problem solving and reasoning skills.
• Demonstrated ability to deliver effective troubleshooting solutions under tight timelines and delivery pressures while maintaining composure and strong performance.
• Effective interpersonal, written and oral communication skills.

Limited handling of laboratory equipment, chemicals, and biological materials

While performing the duties of this job the contractor is frequently required to stand, walk, use hands to fingers, handle or feel objects, tools, or controls; reach with hands or arms; climb or balance; stoop, kneel, crouch, or crawl; and talk and hear.

The contractor must frequently lift and or move up to 50 pounds.