MEP Commissioning Manager

Added - 10/12/21 MEP Commissioning Manager Commissioning Danville , Pennsylvania | Direct Hire



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Job Description

Castle & Associates

We are real-world professionals leveraging forty years of experience in design, construction, real estate, and public accounting. We understand what makes a company great, a project great, an opportunity great and a candidate great. We understand because we are professionals, too. Contact us today to learn how the team at Castle can help you.

www.teamwithcastle.com

Title: MEP Commissioning Manager

Location: Danville, PA/Blue Bell, PA

Position Type: Direct Placement

Level: Manager

Responsibilities:

• Performs “non-pharma and cGMP commissioning-based services with primary focus on standalone commissioning
• Consults on and manages commissioning projects as developed and defined in project agreements with clients
• Performs site auditing, quality reviews, and commissioning services as required to meet project requirements
• Develops business opportunities and projects with primary focus on commissioning and related consulting
• Provides client management functions
• Demonstrated / recognized areas of expertise by industry in start-up and commissioning
• Support, train, mentor, and provide guidance to Commissioning Consultants and overall department staff in the delivery of commissioning services and areas of expertise
• Point of contact to client for overall MEP project delivery
• Runs meetings, communicates status and project issues, frequently “checks-in” with client representative(s), and facilitates general project coordination activities
• Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
  • C/Q/V Master Plans
  • Commissioning Forms
  • C/Q/V Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)
  • FATS/SATs
• Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• Audit project deliverables to assure compliance with established standards
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries

Qualifications:

• Bachelor's degree in Engineering or equivalent technical degree
• Project Management Professional (PMP) certification or Professional Engineer (PE) license desirable
• A minimum of 7 years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus
• Experience with Risk-Based Approach to Commissioning and Qualification

• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes is beneficial