Validation Engineer II

Job Description

At IPS, we are global leaders in developing innovative solutions for 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 CVQ Engineer II 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.
  • 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.)
  • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
  • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • 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, of project status and issues, as requested.

• Bachelor of Science in Engineering.
• 2+ years of relevant work experience.
• This is an entry‑level position.
• 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 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.

• 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.

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…