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Calibration Metrology Project Manager (cGMP – Pharmaceutical) JD817757

JD817757

DPS is looking for a knowledgeable Calibration Project Manager to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of biotech and pharmaceutical GMP industries and will be expected to provide an assessment of their calibration program and help implement technical improvements.

Category:
Engineer Instrument
Location:
Massachusetts
Years of Experience Req.:
10+
Date Posted:
01/01/2019
Days Remaining:
40
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Calibration Project Manager (cGMP – Pharmaceutical)            JD817757

Boston, MA area

 

DPS is looking for a knowledgeable Calibration Project Manager to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of biotech and pharmaceutical GMP industries and will be expected to provide an assessment of their calibration program and help implement technical improvements.


Responsibilities:

  • Responsible for performing a gap assessment/gap analysis of the current calibration program; including the current policies and procedures, internal practices, calibration vendor services, etc.
  • Responsible for providing technical improvements the calibration program; including writing procedures, creating project plans, training, etc.
  • Prepare, maintain, and follow procedures for the maintenance, calibration, and metrology systems and associated processes to adhere to cGMPs, company, local and state requirements.
  • Support efforts to analyz684626.338115e and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
  • Review Calibration/Maintenance Paperwork.
  • Evaluate breakdown and calibration statistics and adjust plans to suit.
  • Increase overall instrument performance through optimiz684626.338115ation of calibration activities.
  • Monitor instrument calibration results and implement corrective actions for out of specification conditions.
  • Serve as subject matter expert on the Maintenance and Calibration systems.
  • Develop, review, revise, and maintain SOPs for all Metrology/Calibration processes.

 

Qualifications:

  • Advanced mechanical/electrical training and/or a Technical Associate's degree or Bachelor's Degree preferred.
  • Must have specific experience with GAMP and ISPE standards.
  • Minimum 10 years of experience in pharmaceutical or similar regulated industry preferred.
  • Must be a creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills.
  • Ability to acquire data, to organiz684626.338115e, to analyz684626.338115e, and reach accurate conclusions.
  •  Working knowledge of statistical methods used to develop metrics.
  • Understanding of maintenance and calibration strategies and techniques.
  • Understanding of engineering principles as they apply to scientific instruments.
  • Experience with process, plant, and other utility systems and equipment.
  • Detailed knowledge of Process Control and Instrumentation Systems.
  • Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing.
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