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A privately held contract manufacturer of personal care and OTC products is building out its validation function to support rapid expansion of its over-the-counter (OTC) drug manufacturing division. This is a newly created role, not a backfill, and the person who takes it will have real ownership of how the program grows.
Pave Talent is hiring on behalf of our client.
- You like owning a function, not just executing tasks someone else designed
- You're comfortable being the subject matter expert in the room on validation topics
- You prefer a fast-moving, hands-on environment over a slow corporate one
- You can manage multiple validation projects simultaneously without a lot of hand-holding
- You want to see the direct impact of your work on a real, growing manufacturing operation
This role is NOT for someone who needs heavy structure, close supervision, or a fully built playbook to follow. The company is growing fast, and the Validation Engineer is expected to grow with it.
Our client operates a 200,000+ square foot personal care and OTC manufacturing facility in Ottawa, Illinois with 400+ employees. The company has grown consistently, including through the pandemic, and is now scaling its OTC division significantly. With that growth comes a pipeline of validation work: tanks, filling lines, cleaning procedures, utility systems, and more. The company recently completed validation of its water system and has a queue of projects ready to go.
You'll report directly to R&D and Regulatory Affairs leadership and work cross-functionally with Engineering, Quality Assurance, and Operations. The role is on-site, Monday through Friday, with flexibility expected for special projects and new equipment installations.
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- Develop, write, and execute IQ/OQ/PQ protocols for manufacturing equipment, filling lines, tanks, utility systems, and cleaning procedures
- Own the validation master plan and maintain validated status per FDA cGMP requirements (21 CFR Parts 210/211)
- Perform cleaning validation and sanitization validation studies for OTC drug product manufacturing
- Write and maintain SOPs, protocols, interim reports, and final reports for audit readiness
- Partner with Engineering on new equipment purchases and installations from day one
- Serve as the subject matter expert on validation during internal and external audits and inspections
- Investigate deviations, equipment failures, and out-of-specification events related to validated systems
- Stay current on FDA guidance documents, USP chapters, and industry best practices
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- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Chemistry, or related technical field
- 3 to 5 years of hands-on validation experience in a cGMP manufacturing environment
- Demonstrated IQ/OQ/PQ protocol development and execution (not just review or oversight)
- Experience validating equipment, cleaning procedures, and/or utility systems
- Strong technical writing skills across SOPs, protocols, and validation reports
- Working knowledge of FDA cGMP regulations (21 CFR Parts 210/211)
- Ability to independently manage multiple validation projects with minimal supervision
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- Personal care, OTC, or cosmetics manufacturing background
- Pharmaceutical validation experience (the work translates directly)
- Familiarity with USP water system validation or computer system validation (CSV)
- Lean Six Sigma certification or training
- Experience supporting FDA inspections or customer audits
Note on industry background: personal care and OTC experience is preferred, but candidates from pharmaceutical manufacturing are strongly encouraged to apply. If you have validated equipment, cleaning procedures, or utility systems in a pharma cGMP environment, your background is directly relevant to what this team needs.
: Monday through Friday, on-site; flexibility required for special projects
: Relocation assistance available for the right candidate
: Medical, dental, vision, and 401(k) (details to be confirmed)
: Competitive pay
Interested? Apply and we'll be in touch. Confidential search; your application is fully private.
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