Scope of Function:
Maintenance Mechanic is responsible for all routine maintenance activities on GMP support equipment and systems. This candidate should be able to follow preventative maintenance Standard Operating Procedures (SOP), and company policies to ensure prompt completion of important tasks to support company goals and clients projects. It's required for this candidate to have at least 3-5 years experience on GMP manufacturing operations. It's desired a candidate with experience on biotech equipment and systems like mechanical seal for cell culture bioreactors, ISO-5 incubators, centrifuges, etc.
1) Ensures scheduled maintenance activities are performed in a timely manner by providing timely verbal and/or written notice to department users and engineering.
2) Responsible for the routine preventative maintenance and daily inspection of GMP Utilities Systems to ensure prompt support to all manufacturing operations.
3) Responsible for the routine maintenance of laboratory and manufacturing support equipment.
4) The candidate for this position needs to have the ability to lift up to 50lbs of weight.
5) Responsible for the creation, revision and execution of preventive maintenance SOPs for a variety of equipment and systems.
6) It's desired a candidate with experience with other utilities systems like HPW Systems, CIP Skids, PH Neutralization, and HVAC Systems.
7) Propose and review equipment and system maintenance requirements.
8) Provide guidance to others within the laboratory in assessing measurement process variability and uncertainty.
9) Interprets records and verifies test data, comparing to known standards and criteria.
10) Maintain records within the preventive maintenance/calibration database (CalMan).
11) Responsible for the scheduling of maintenance activities for equipment and systems using contract personnel.
12) Responsible for reviewing maintenance documentation generated in house or by outside vendors to ensure they are in accordance with the company quality systems and cGMP regulations.
13) Responsible for the creation of requirements, specifications, protocols, reports, deviations, change controls, and test documentation.
14) Develop and implement solutions to maintenance issues and recommend quality improvement strategies.
15) Working with vendors and contract personnel to ensure maintenance activities are performed in accordance with industry standards and GMP requirements, and are responsible to ensure that the documentation is appropriately reviewed.
16) When it's needed, this candidate will have to respond to emergency alarm events from the environmental monitoring system.
Education and Skills Required:
Education: An Associate's degree on Mechanical, Chemical or Electrical Engineer is desired. A candidate with training courses on maintenance activities described above is preferred.
Experience: A minimum of 3-5 years experience on biopharmaceutical GMP environment is required. A candidate with experience on biotech manufacturing and process equipment is preferred.
Skills: Good mechanical skills. Ability to create and execute preventative maintenance SOPs for variety biotech/pharmaceutical equipment and systems. This candidate needs to have good work ethics and good aptitude to respond to day in and day out challenges.