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.
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
Bachelors 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 analyz860###.####03e data.
Strong organiz860###.####03ational skills, oral and written communication and team attitude.