CQV, Project Leader

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 CQV Project Leader to join our team out of our office located in ____________.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. Interfaces directly with IPS clients in the delivery of projects. May also manage and perform standalone commissioning services for non-FDA regulated clients.

Position Responsibilities

• Assists an assigned Project Manager or is solely responsible for the successful delivery of compliance projects to IPS' clients.
• Provides consistent, complete, and timely feedback and reports to IPS project managers or management of project status and issues.
• Develops project schedules, deliverable tracking reports, scope adjustment notices, etc.
• Supports, trains, and guides validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
• Writes and manages 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
• Manages 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, witnessing of vendor start-up, and testing
  • Execution of C/Q/V protocols
  • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
  • Assists in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Coordinates with the Project Delivery department or CM for start-up and vendor testing.
  • Assists in proposal development including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
• C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.

Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and takes your career to new heights!

• A Bachelor of Science in Engineering is required for an Engineer; a Bachelor of Science in a related field is required for a Validation Specialist.
• 5+ 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 and protocols for GMP Utilities, Equipment, Systems, and Software.
• Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes is beneficial.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical.
• Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
• Experience with a Risk-Based Approach to Commissioning and Qualification is beneficial.
• Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
• Demonstrated knowledge of Project Management Principles.

All interviews are conducted either in person or virtually, with video required.

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!