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

Summary

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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.

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.

- 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.

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.

'

- 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

:

- 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

:

- 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

: 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.

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

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

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

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

: Relocation assistance available for the right candidate

Interested? Apply via LinkedIn and we'll be in touch. Your application stays private.

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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.

Job Description

-- () , .

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.

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.

- 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.

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.

'

- 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

:

- 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

:

- 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

: 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.

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

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

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

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

: Relocation assistance available for the right candidate

Interested? Apply via LinkedIn and we'll be in touch. Your application stays private.

|

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.