Global leader in the healthcare/medical product manufacturing industry is looking a Validation Associate in Round Lake IL. This is a contract position expected to last 10 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Supporting system owners with the generation and management of documentation associated with Medical Products instrument validation and qualification activities
- Activity focus on laboratory equipment and instrument systems (LE&IS) utilized in the engineering, chemistry, and information technology areas
- All activities will be performed in compliance with internal procedures and international/national regulations
- B.S.in Engineering
- 3 yrs in GMP-regulated industry, preferably medical device or pharmaceutical
- Hands-on experience with process validation and Computer System Validation with strong knowledge of FDA 21 CFR Part 11, 21 CFR Part 820 and other GxP Regulations
- Experience in Equipment Qualification, Process validation and Computer System Validation
- Experience in validation activities including factory acceptance testing (FAT), facilities, utilities, manufacturing equipment and laboratory equipment qualification and temperature mapping
- Experience in developing the following validation deliverables - Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ, Deviation/Incident Reports, Change Controls and Problem Reports
- Experience in executing protocols including complex systems such as computer controlled systems, complex utilities, manufacturing equipment and laboratory equipment
<Benefits for the Validation Engineer
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.