About this opportunity
Pave Talent lists this Validation Engineer, cGMP and OTC Drug Product Manufacturing, Build and Own a Brand-New Validation Program (Relocation Assistance) - 3684350 opportunity in ottawa, Illinois. Review the employerโs description below for duties, qualifications and application requirements.
Job description
๐ข๐๐ป ๐ฎ ๐๐ฎ๐น๐ถ๐ฑ๐ฎ๐๐ถ๐ผ๐ป ๐ฝ๐ฟ๐ผ๐ด๐ฟ๐ฎ๐บ ๐ณ๐ฟ๐ผ๐บ ๐๐ต๐ฒ ๐ด๐ฟ๐ผ๐๐ป๐ฑ ๐๐ฝ ๐ฎ๐ ๐ฎ ๐ด๐ฟ๐ผ๐๐ถ๐ป๐ด ๐ฝ๐ฒ๐ฟ๐๐ผ๐ป๐ฎ๐น ๐ฐ๐ฎ๐ฟ๐ฒ ๐ฎ๐ป๐ฑ ๐ผ๐๐ฒ๐ฟ-๐๐ต๐ฒ-๐ฐ๐ผ๐๐ป๐๐ฒ๐ฟ (๐ข๐ง๐) ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ฒ๐ฟ, ๐๐ถ๐๐ต ๐๐ต๐ฒ ๐๐ฐ๐ผ๐ฝ๐ฒ ๐ฎ๐ป๐ฑ ๐๐ต๐ฒ ๐ฎ๐๐๐ผ๐ป๐ผ๐บ๐ ๐๐ผ ๐ฏ๐๐ถ๐น๐ฑ ๐ถ๐ ๐๐ต๐ฒ ๐๐ฎ๐ ๐ถ๐ ๐๐ต๐ผ๐๐น๐ฑ ๐ฏ๐ฒ ๐ฏ๐๐ถ๐น๐.
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.
๐๐ข๐ ๐ฃ๐๐ก๐ฌ
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.
๐ช๐ต๐ผ ๐๐ต๐ฟ๐ถ๐๐ฒ๐ ๐ต๐ฒ๐ฟ๐ฒ
- 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.
๐ง๐๐ ๐ข๐ฃ๐ฃ๐ข๐ฅ๐ง๐จ๐ก๐๐ง๐ฌ
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.
๐ช๐๐๐ง ๐ฌ๐ข๐จ'๐๐ ๐ข๐ช๐ก
- 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
๐ค๐จ๐๐๐๐๐๐๐๐ง๐๐ข๐ก๐ฆ
๐ฅ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐ฑ:
- 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
๐๐ผ๐ป๐๐ ๐ฃ๐ผ๐ถ๐ป๐๐:
- 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
๐ ๐ป๐ผ๐๐ฒ ๐ผ๐ป ๐ถ๐ป๐ฑ๐๐๐๐ฟ๐ ๐ฏ๐ฎ๐ฐ๐ธ๐ด๐ฟ๐ผ๐๐ป๐ฑ: 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.
๐๐ข๐ ๐ฃ๐๐ก๐ฆ๐๐ง๐๐ข๐ก ๐๐ก๐ ๐๐๐ก๐๐๐๐ง๐ฆ
๐๐ผ๐บ๐ฝ๐ฒ๐ป๐๐ฎ๐๐ถ๐ผ๐ป: Competitive base salary, depending on experience. We share the full range on our first call.
๐๐ผ๐ป๐๐: No annual bonus. This is a straight salary role, and we would rather tell you that up front.
๐ฆ๐ฐ๐ต๐ฒ๐ฑ๐๐น๐ฒ: Monday through Friday, with flexibility when new equipment installations and special projects call for it
๐๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: On-site in Ottawa, Illinois, about 85 miles southwest of Chicago
๐ฅ๐ฒ๐น๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: Relocation assistance available for the right candidate
Interested? Apply via LinkedIn and we'll be in touch. Your application stays private.
๐ฃ๐ฎ๐๐ฒ ๐ง๐ฎ๐น๐ฒ๐ป๐ | ๐๐ถ๐ฟ๐ถ๐ป๐ด ๐ฅ๐ฒ๐ถ๐บ๐ฎ๐ด๐ถ๐ป๐ฒ๐ฑ
Pave Talent and our client are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
Worksite address
ottawa, IL, 61350, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.