Sigan America LLC
Join Sigan America LLC as a Validation Engineer in our Ottawa, LaSalle County manufacturing facility. We're hiring a full-time professional to ensure our operations meet regulated industry standards through comprehensive equipment, system, and process validation.
About the Role
This is a full-time, on-site position focused on maintaining validation compliance across our cGMP manufacturing environment. You'll design, execute, and document validation protocols that keep our operations aligned with pharmaceutical and regulated industry requirements. Your work directly supports product quality and regulatory compliance.
What You'll Do
- Develop and implement validation strategies for manufacturing equipment, facility systems, and utilities
- Execute qualification and validation studies (IQ, OQ, PQ) on production processes and computerized systems
- Create and maintain comprehensive validation documentation and reports
- Collaborate with manufacturing, engineering, and quality teams to resolve validation findings
- Support regulatory inspections and audits with accurate validation records
- Conduct process validation studies to demonstrate reproducibility and consistency
- Evaluate new equipment and systems for validation requirements before implementation
What We're Looking For
- Experience in validation engineering or a related quality discipline in regulated manufacturing
- Strong knowledge of cGMP requirements and validation principles (ICH Q7, FDA guidelines)
- Proficiency with validation protocols, risk assessment, and statistical analysis
- Technical expertise with manufacturing equipment, HVAC systems, or process systems
- Experience validating computerized systems and data integrity controls
- Excellent written and verbal communication skills for documentation and cross-functional teamwork
- Bachelor's degree in engineering, chemistry, life sciences, or related field (or equivalent professional experience)
- Ability to manage multiple validation projects and meet regulatory timelines
About Sigan America LLC
Sigan America LLC is a regulated manufacturing organization committed to quality, compliance, and operational excellence. We support our team with clear expectations, professional development, and the tools needed to succeed in a quality-focused environment.
How to Apply
Apply through this listing to join our team in Ottawa, LaSalle County. Include your résumé and any relevant validation or manufacturing certifications.
To apply for this job please visit www.adzuna.com.
About this role & career path
Working in Ottawa, Canada
Ottawa is the capital city of Canada. It is located in the southeastern portion of the province of Ontario, at the confluence of the Ottawa River and the Rideau River. Ottawa borders Gatineau, Quebec, and forms the core of the Ottawa–Gatineau census metropolitan area (CMA) and the National Capital Region (NCR). As of 2021, Ottawa had a city population of 1,017,449 and a metropolitan population of 1,488,307, making it the fourth-largest city and fourth-largest metropolitan area in Canada.
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