Validation Engineer
Sigan America LLC
Job Description
Job Description
Senior Validation Engineer
Location: Ottawa, Illinois
Employment Type: Full-Time
About the Position
We are seeking an experienced Senior Validation Engineer to lead validation activities supporting our cGMP manufacturing operations. This role is responsible for validating equipment, facilities, utilities, manufacturing processes, and computerized systems while ensuring compliance with FDA cGMP requirements and industry best practices.
The ideal candidate has a strong technical background in pharmaceutical, medical device, cosmetic, or regulated manufacturing environments and enjoys working cross-functionally with Engineering, Quality, Manufacturing, Regulatory Affairs, Maintenance, and R&D.
Key Responsibilities
- Develop, review, and execute IQ, OQ, and PQ validation protocols.
- Plan and execute validation activities for new equipment, facilities, utilities, and manufacturing processes.
- Support new product launches and continuous process improvement initiatives.
- Prepare validation reports and maintain complete validation documentation.
- Lead equipment qualification and process validation projects from planning through implementation.
- Support engineering change controls and assess validation impact for equipment and process changes.
- Perform periodic reviews and revalidation of equipment, utilities, and manufacturing processes.
- Ensure compliance with FDA cGMP regulations, ISPE guidance, and internal quality standards.
- Maintain validation records, equipment logbooks, and supporting documentation.
- Collaborate with Maintenance, Engineering, Manufacturing, Quality Assurance, Regulatory Affairs, and R&D to resolve technical issues and implement improvements.
- Identify opportunities to improve validation systems, documentation, and overall compliance.
Systems & Equipment Experience
Experience validating one or more of the following is highly desirable:
- HVAC systems
- Purified Water / RODI Water Systems
- Compressed Air and Gas Systems
- Boilers and Chillers
- Temperature- and Humidity-Controlled Rooms
- Refrigerators, Freezers, and Incubators
- Manufacturing Equipment
- Laboratory Equipment
- Computerized Systems and 21 CFR Part 11 Compliance
Qualifications
Required
- Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).
- 3–5+ years of validation experience in a pharmaceutical, medical device, cosmetic, or other FDA-regulated manufacturing environment.
- Experience developing and executing IQ/OQ/PQ protocols.
- Experience with equipment, facility, utility, and process validation.
- Experience with engineering change controls and validation documentation.
- Strong technical writing and documentation skills.
- Excellent organizational skills with exceptional attention to detail.
- Ability to manage multiple projects while meeting deadlines.
Preferred
- Experience performing temperature mapping of refrigerators, freezers, incubators, warehouses, or controlled environments.
- Experience with software validation and 21 CFR Part 11 compliance.
- Experience completing validation periodic reviews.
- Knowledge of risk-based validation methodologies.
- Familiarity with Lean Manufacturing or Continuous Improvement initiatives.
What We're Looking For
The successful candidate is a hands-on validation professional who enjoys solving technical problems, improving manufacturing processes, and working collaboratively across departments. This individual is organized, detail-oriented, and committed to maintaining the highest standards of quality and regulatory compliance.
Competitive salary and comprehensive benefits package offered based on experience.
\nCompany Description About Us
Fast growing liquid pour contract manufacturer of premium health and beauty products.
Company Description
About Us\r\nFast growing liquid pour contract manufacturer of premium health and beauty products.
Vacancy posted 12 days ago
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