Location: Indianapolis
Summary
The Process Mechanic will report to the Head of Engineering Services and be responsible for oversight and performing general and preventative maintenance of all GMP production equipment. Additionally, the Process Mechanic will perform calibration services and manage calibration services vendors as required. Process Mechanic will be responsible for ensuring all production equipment is operational and ready for GMP use. The Process Mechanic will also work with Supply Chain to ensure replacement components and consumable parts and are available to maintain operational readiness of all production equipment.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Become subject matter expert on all production equipment as required.
- Perform troubleshooting and repairs as required to maintain the operational status of all production equipment.
- Investigate and remediate any failure modes related to robotics, In-Process Analytical Technologies, and measuring equipment within Hot Cells.
- Perform routine calibration and maintenance activities for manufacturing equipment as required. Manage outsource calibration and OEM vendors.
- Conduct preventative maintenance following GMP and GDP practices.
- Manage asset lifecycle within CMMS (asset enrollment, routine use and maintenance, decommissioning, etc.)
- Support laboratory investigations and CAPA’s related to production equipment.
- Provide operations support and training of Operations staff as required.
- Draft work instructions in support of manufacturing operations as required.
- Comply with radiation safety procedures and policies
- 10% of travel may be required
Education and Experience
- Associates or Bachelors degree in scientific field and/or 5+ years hands-on plant maintenance experience in a GMP manufacturing facility.
Skills and Qualifications
- Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (FDA, USP, OSHA, etc.)
- Proficiency with MS Office Suite
- Working knowledge of electrical, automation systems and robotics
- Basic knowledge of Environmental Monitoring, Building Automation, and CMMS systems and architecture.
- Must be willing to work around radioactive materials.
- Must be willing to work in clean room environments.
- Familiarity with PLC control systems and instrumentation bus technologies.
- Ability to read mechanical drawings, electrical schematics and P&IDs.
- Good understanding of GMPs with experience in pharmaceutical environment preferred. Experience in regulated industry a plus.
- Must be flexible to work weekends, and holidays as required
Physical Demands
- Ability to climb ladders and lift up to 50 lbs.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
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