Senior Validation Engineer

About the company

Our client is a specialist engineering and consultancy business serving the life sciences sector. Its teams work with pharmaceutical and biotech manufacturers on the full lifecycle of a facility: process and automation design, project delivery, commissioning, qualification and regulatory compliance.

About the project

You'll join a live, fully funded project at a GMP manufacturing site in the Chicago area. The facility is expanding its existing plant and moving its control system to a newer DeltaV release (v13 to v15). The work involves retiring legacy systems, bringing the new platform online, and making sure every system, software change and supporting process is properly specified, tested and documented to regulatory and quality standards.

The project is growing, so there are two openings:

• Senior Engineer / Team Lead: leads a small team of CQV/CSV engineers (three now, and growing) and manages their day-to-day workload while staying hands-on.
• Mid-Level Engineer: a hands-on delivery role supporting qualification and validation work across the brownfield scope.

What you'll be doing

• Write, maintain and roll out the quality and validation documents that support good qualification practice on site
• Prepare lifecycle deliverables, including user requirement specifications and IQ, OQ and PQ protocols, and execute them in line with Good Documentation Practice and site quality procedures
• Plan test strategies, using statistical justification where needed; run or coordinate execution; evaluate the results; and write the summary reports
• Review DeltaV configuration, software documentation and functional specifications to build test scripts for new code and changes
• Carry out data integrity reviews and assess computerised systems against 21 CFR Part 11
• Help define user and functional requirements for new or modified process equipment, and work with equipment vendors to make sure those requirements are met
• Work with manufacturing, R&D and other non-engineering colleagues on technology transfer and system improvements
• Keep deliverables on schedule and raise risks or delays early with project leadership
• Follow all regulatory, company and quality procedures
• Senior only: allocate work, mentor and develop direct reports, and be the team's main point of contact with project leadership

What we're looking for

• Bachelor's or Master's degree in engineering or a related technical field
• Senior: 10–15 years in CQV/CSV in an FDA-regulated, GMP environment, including experience leading or supervising engineers
• Mid-Level: around 5 years in a similar environment
• Strong candidates with slightly less experience will be considered if they can show they can do the job
• Hands-on DeltaV experience: reviewing configuration and specifications, and writing and executing test protocols for software changes and modifications
• Proven end-to-end CQV delivery, from requirements through IQ/OQ/PQ execution to final reporting
• Experience with upstream or downstream bioprocessing equipment
• Solid knowledge of the CSV lifecycle and its documents (URS, FRS, DS, validation master plans, PV), and of quality systems such as change control, deviations and requalification
• Clear technical writing and communication, and comfortable presenting findings
• Organised and self-motivated, and able to manage several workstreams at once
• Proficient in Microsoft Word, Excel and PowerPoint

Working arrangements

• Fully site-based, standard 40-hour week, with overtime available on approval
• Occasional paid travel to vendor sites for Factory Acceptance Testing (FAT)
• Mileage to site is reimbursed
• Local candidates are preferred – Relocation assistance can be provided