Lead GMP Tech

23 hours ago

Boston MA United States C&W Services Full time

Job Title : Lead GMP Tech

Job Description Summary

The Lead GMP Tech is responsible for maintaining and documenting specific Vertex GMP facility, manufacturing, and R&D lab equipment maintenance through its entire life cycle from installation through decommissioning. They work directly with the end users, vendors, and Quality Assurance to support GMP API and OSD manufacturing operations through the troubleshooting of operational issues and preventive and corrective maintenance, qualification, and calibration of all assets identified as part of the equipment maintenance program.

KEY DUTIES AND RESPONSIBILITIES:

  1. Executes corrective and preventive maintenance related to specific oral solid dosage manufacturing equipment and qualified utilities including work methods, procedures and documentation within a validated CMMS system.
  2. Oversees and escorts non-resident contractors and suppliers to execute corrective and preventive maintenance.
  3. Investigates opportunities for improvement and implements best practices.
  4. Reviews and approves vendor documentation to ensure that accurate, concise documentation is submitted and meets all the requirements of GMP's and internal SOP's.
  5. Provides technical support for troubleshooting, improving, or optimizing ongoing facility and manufacturing operations.
  6. Works with vendors, suppliers, and contractors to effectively execute required maintenance, calibration and qualification activities.

KNOWLEDGE AND SKILLS:

  1. Demonstrated hands-on experience with mechanical, electrical, pneumatic, hydraulic, electronic, and plumbing equipment and tools.
  2. Demonstrated ability to operate independently and without direct supervision while seamlessly integrating into a team atmosphere.
  3. Strong troubleshooting and repair skills.
  4. Experience with operating EMS, BMS & CMMS systems.
  5. Physical abilities include but not limited to, lifting objects up to 50lbs, able to be on feet all day, climb steps and ladders as required by job, wear PPE to include respiratory protection.
  6. Strong interpersonal, verbal and written communication skills.
  7. Understands FMECA and RCA and their application in an industrial environment.
  8. Technical certification(s) or licensure within industry recognized areas, i.e. trade license (Journeyman or higher).
  9. AS in Engineering Technology or related field preferred, not required.

EDUCATION AND EXPERIENCE:

  1. High school or secondary school diploma.
  2. Typically requires 3 years of experience working with pharmaceutical manufacturing equipment, specifically, oral solid dosage equipment, or the equivalent combination of education and experience.

C&W Services is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, protected veteran status or any other characteristic protected by law.

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