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Senior Utilities Project Manager (cGMP – Pharmaceutical) JD817689

JD817689

DPS is looking for a Senior Utilities Project Manager to work with a BioPharma client in the MA area. Ideal candidates should have strong experience with clean and plant utility systems including but not limited to WFI, Clean Steam, HVAC, and other related systems. This individual must also have strong previous biologics and capital projects experience.

Category:
Project Engineer
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
15/07/2019
Days Remaining:
26
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Utilities Project Manager (cGMP – Pharmaceutical)            JD817689

Boston, MA area

 

Summary:

                        

DPS is looking for a Senior Utilities Project Manager to work with a BioPharma client in the MA area. Ideal candidates should have strong experience with clean and plant utility systems including but not limited to WFI, Clean Steam, HVAC, and other related systems.
 

This individual must also have strong previous biologics and capital projects experience.

 

Responsibilities:

  • Assist with development of system boundaries and criticality assessments.
  • Review system specifications and component data sheets.
  • Manage P&IDs and incorporate redlines when/if design changes are required.
  • Attend equipment FATs and author or contribute to development of test documents.
  • Assist manufacturing with system shakedown, start-up and troubleshooting.
  • Review Submittals/Design Packages/RFIs and ETOPs for accuracy and completeness.
  • Facilitate/participate in formal design reviews and design qualifications.
  • Assist automation and manufacturing with development of sequence of operations and phase flow paths for FRS/DDS development.
  • Assist in development of spare parts lists for input to CMMS.
  • Design and perform Engineering studies, as required.

Skills & Education                                                           

  • Bachelor’s degree in Mechanical Engineering or a related discipline.
  • Minimum of 8+ years’ experience working with MEP within the biopharmaceutical or life science industries.
  • Special knowledge requirements include biopharmaceutical and pharmaceutical process and facility design approaches, plus a solid understanding of cGMP requirements.
  • Must have superior understanding of MEP and clean utility systems.
  • Must have experience with leading mid-to-large capital projects for the pharmaceutical industry.
  • Must have experience with leading Utility Design requirements for mid-to-large capital projects for the pharmaceutical industry.
  • Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).
  • Ability to compile and analyz812644.70486e data.
  • Strong organiz812644.70486ational skills, oral and written communication and team attitude.
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