Senior CQV Engineer

Overview

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Senior CQV Engineer to join our team at 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. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.

• Write C/Q/V documents following established standards and templates, including but not limited to:
  • Commissioning Forms
  • C/Q/V Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)
  • FATS/SATs
• Perform field/site activities including, but not limited to:
  • Attend and witness FATs and SATs as a representative of IPS clients
  • Execute commissioning forms and witness vendor start-up and testing
  • Execute C/Q/V protocols
  • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
  • Compile data and prepare reports for completed C/Q/V activities including ETOPs and protocol data packages
  • Assist in deviation investigation and resolution of problems during field execution
  • Work with the Project Delivery department or CM for start-up and vendor testing; witness and troubleshoot as required
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries
• Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
• Perform work to meet IPS budget requirements and quality standards; provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, as requested

• Bachelor of Science in Engineering
• This is an entry-level position
• 7 or more years of relevant experience
• 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
• General exposure and experience in a GMP/Validation discipline with knowledge of pharmaceutical Design/Build/Commission/Validation processes and regulatory requirements and cGMP regulations within the EU and US FDA

• This position will have up to 100% travel to the site, or as required by the assigned project
• You may be assigned to a 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
• You may visit active construction sites and will be required to take site safety training and adhere to site safety rules
• This position is a safety-sensitive position
• The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other non-administrative areas

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

IPS, a Berkshire Hathaway company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services to help clients develop and manufacture life-impacting products. IPS has over 3,500 professionals in over 45 offices across 17 countries. For further information, please visit

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.

Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Resumes submitted without a valid written search agreement in place will be deemed the sole property of IPS, and no fee will be paid if a…