CQV Project Manager

Job Description

At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a dedicated Project
Manager
of CQV to join our team at our office located in __________.

• Directly responsible for the successful delivery of commissioning and compliance projects to IPS' clients.
• Leads multiple concurrent small, mid-sized, or large projects on behalf of IPS.
• IPS point of contact to the client for overall project delivery. Runs meetings, communicates status and project issues, frequently checks in with client representative(s), and facilitates general project coordination activities.
• Coordinates project activities with the IPS Project Lead.
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS clients or management on project status and issues.
• Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
• Support, train, mentor, and guide commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
• Assist or take lead in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
• 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
• Perform and manage others during field/site activities, including, but not limited to, the following:
  • Attend and witness FATs and SATs as a representative of IPS clients.
  • Execution of commissioning forms and witnessing of vendor start-up and testing.
  • Execution of C/Q/V protocols.
  • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• Perform and manage staff in compiling data packages and preparing reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
• Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.
• Audit project deliverables to assure compliance with established standards.
• Review the work of the assigned project team.
• Ensure the quality of the IPS project work.
• Act as an IPS representative for developing new opportunities and continue to support repeat business.
• Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.).
• Provide working knowledge in the delivery of technical projects in these areas.
• Develop client relationships and act as IPS liaison (point of contact) on project/client sites.
• Assist in recruiting new staff members and promoting IPS to potential hires.
• Make recommendations to IPS for possible project and procedural improvements.
• Other duties as assigned.

• Bachelor's degree in Engineering, Project Delivery, or a related discipline, or an equivalent technical degree.
• 7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• 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.
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes.
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• Project Management Professional (PMP) certification or Professional Engineer (PE) license.

• Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
• Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.

• Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
• Can adhere to strict cleanroom gowning protocols.

• This position will have up to 50% travel, or as required by the assigned project.
• Position may be assigned to the client site for an extended period.
• Overnight travel or staying in the city of the Client's location is possible, depending on the assignment.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• Must have access to reliable transportation.

• This position is a…