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Engineer, Mechanical Maintenance

3 months ago

Pennington, United States ProBio Full time

Job Scope:

The Engineer, Mechanical Maintenance is responsible for the manufacturing and laboratory equipment at the site. This includes performing activities and overseeing outside vendor activities required to support the Preventative Maintenance and Corrective Maintenance program in accordance with Good Manufacturing Procedures (GMP) regulations and company Standard Operating Procedures (SOPs). This includes ensuring that these activities are properly documented.

Instrument services may be performed in but not limited to GMP, Good Lab Practices (GLP), Non-GMP process and laboratory areas.


Essential responsibilities:

Performs daily monitoring, preventative maintenance, and repairs of manufacturing and laboratory equipment in accordance with SOPs, ensures proper documentation practices are followed and ensures that there is minimal or no interruption in the daily manufacturing schedules.

  1. Maintains and performs corrective and preventative maintenance and calibrations on GMP and non-GMP equipment.
  2. Supports other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems.
  3. Participates in the continuous improvement efforts within the site Maintenance Program.
  4. Assists in the maintenance and review of calibration standards and vendor calibration documentation.
  5. Provides support for start-up, commissioning, and turnover of new systems.
  6. Perform preventative and predictive maintenance on related clean utilities and systems that support Process Manufacturing.
  7. Maintains water rooms and related equipment. This includes, but may not be limited to, pumps, motors, Deionized Water System, WFI stills, Clean Steam Generators and related piping.
  8. Maintains all site refrigerators and freezers.
  9. Troubleshoots and repairs all related clean utility equipment and systems and Water for Injection (WFI) point of use flushing.
  10. Maintains documents and records on all validated equipment and systems.
  11. Interfaces with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems.
  12. Maintains up to date training records.
  13. Communicates with management regarding change documentation, as necessary.
  14. Follows current Good Manufacturing Practices (cGMPs).
  15. Communicates and coordinates with each department and within Facilities Management when planned and unplanned work events occur.
  16. Performs other tasks and assignments as needed and specified by management.


Qualifications:

  1. A High School diploma and a minimum of 6 years of facilities maintenance/operations experience in a pharmaceutical, biotechnology or related environment OR the equivalent combination of education and experience. Advanced knowledge of Preventive Maintenance and calibration disciplines within a cGMP Biotechnology, Pharmaceutical or related manufacturing environment.
  2. Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life
  3. Cycle (SDLC) regulations, knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  4. Proficiency with Computerized Maintenance Management Systems (CMMS).
  5. Proficiency with Microsoft Office.
  6. Excellent verbal and written communication and skills.
  7. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  8. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  9. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.