Validation Engineer, cGMP and OTC Drug Product Manufacturing, Build and Own a Brand-New Validation Program (Relocation Assistance) - 3684350

𝗢𝘄𝗻 𝗮 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗴𝗿𝗮𝗺 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗴𝗿𝗼𝘂𝗻𝗱 𝘂𝗽 𝗮𝘁 𝗮 𝗴𝗿𝗼𝘄𝗶𝗻𝗴 𝗽𝗲𝗿𝘀𝗼𝗻𝗮𝗹 𝗰𝗮𝗿𝗲 𝗮𝗻𝗱 𝗼𝘃𝗲𝗿-𝘁𝗵𝗲-𝗰𝗼𝘂𝗻𝘁𝗲𝗿 (𝗢𝗧𝗖) 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿, 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝘀𝗰𝗼𝗽𝗲 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗮𝘂𝘁𝗼𝗻𝗼𝗺𝘆 𝘁𝗼 𝗯𝘂𝗶𝗹𝗱 𝗶𝘁 𝘁𝗵𝗲 𝘄𝗮𝘆 𝗶𝘁 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲 𝗯𝘂𝗶𝗹𝘁.

This is a newly created position, not a seat someone left behind. Relocation assistance is available, and candidates relocating into the area are encouraged to apply.

𝗖𝗢𝗠𝗣𝗔𝗡𝗬

Pave Talent is hiring on behalf of our client, an established contract manufacturer of over-the-counter (OTC) drug products and consumer health and beauty goods in north central Illinois. The company has grown steadily for years without layoffs or downturns, and is expanding its OTC capabilities. The culture is hands-on: people own their function, make decisions, and execute without a lot of hand-holding.

𝗪𝗵𝗼 𝘁𝗵𝗿𝗶𝘃𝗲𝘀 𝗵𝗲𝗿𝗲

- Builders who want to stand up a validation program, not inherit one where every template and protocol is already written

- People who document rigorously and do not cut corners, because every OTC product released depends on that paperwork holding up

- Engineers comfortable owning a function solo and pulling in research and development (R&D), Quality Assurance (QA), and Operations as needed

If you want a mature validation department with established systems, a team reporting to you, and a narrow slice of scope, this is not your role.

𝗧𝗛𝗘 𝗢𝗣𝗣𝗢𝗥𝗧𝗨𝗡𝗜𝗧𝗬

You will report to R&D and Regulatory Affairs leadership and work directly with QA, Engineering, and Operations. Every piece of equipment, process, cleaning procedure, and utility system in OTC manufacturing has to be formally validated before it can be used in production, which puts you at the front of the company's growth rather than behind it. As the hiring manager put it, with the new OTC products, nothing moves until it is validated.

𝗪𝗛𝗔𝗧 𝗬𝗢𝗨'𝗟𝗟 𝗢𝗪𝗡

- Write and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for process tanks, filling lines, utility systems, and cleaning procedures

- Own the validation master plan and keep all equipment and systems in a validated state under U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) requirements, 21 CFR Parts 210 and 211

- Run cleaning and sanitization validation studies supporting OTC drug product manufacturing

- Write and maintain standard operating procedures (SOPs), protocols, interim reports, and final validation reports that hold up under audit

- Partner with Engineering on new equipment purchases so validation requirements are set before installation, not retrofitted after

- Serve as the validation subject matter expert during customer audits and FDA inspections, and investigate deviations and out-of-specification events on validated systems

𝗤𝗨𝗔𝗟𝗜𝗙𝗜𝗖𝗔𝗧𝗜𝗢𝗡𝗦

𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗱:

- Bachelor's degree in mechanical engineering, chemical engineering, chemistry, or a related technical field

- 3 to 5 years of validation experience in a cGMP manufacturing environment

- Hands-on IQ/OQ/PQ protocol development and execution

- Experience validating equipment, cleaning procedures, or utility systems

- Strong technical writing and working knowledge of 21 CFR Parts 210 and 211

𝗕𝗼𝗻𝘂𝘀 𝗣𝗼𝗶𝗻𝘁𝘀:

- Personal care, cosmetics, or OTC manufacturing background

- United States Pharmacopeia (USP) water system validation

- Computer system validation (CSV)

- Experience supporting FDA inspections or customer audits

- Lean Six Sigma certification or training

𝗔 𝗻𝗼𝘁𝗲 𝗼𝗻 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗯𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱: Personal care and OTC experience is preferred, but pharmaceutical validation translates directly. If you have validated equipment, cleaning procedures, or utility systems in a pharma cGMP environment, you are a strong fit and we want to talk.

𝗖𝗢𝗠𝗣𝗘𝗡𝗦𝗔𝗧𝗜𝗢𝗡 𝗔𝗡𝗗 𝗕𝗘𝗡𝗘𝗙𝗜𝗧𝗦

𝗖𝗼𝗺𝗽𝗲𝗻𝘀𝗮𝘁𝗶𝗼𝗻: Competitive base salary, depending on experience. We share the full range on our first call.

𝗕𝗼𝗻𝘂𝘀: No annual bonus. This is a straight salary role, and we would rather tell you that up front.

𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲: Monday through Friday, with flexibility when new equipment installations and special projects call for it

𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: On-site in Ottawa, Illinois, about 85 miles southwest of Chicago

𝗥𝗲𝗹𝗼𝗰𝗮𝘁𝗶𝗼𝗻: Relocation assistance available for the right candidate

Interested? Apply via LinkedIn and we'll be in touch. Confidential search; your application is fully private.

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