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Title: Validation EngineerHours: Mon- Fri 8:30-5:00pmLocation: Somerset, NJType: Direct HireRequirements:
Bachelor's degree in Engineering, Chemistry, or a related field.
Minimum of 3-5 years of experience in validation within a manufacturing environment, preferably in dietary supplements or pharmaceuticals.
Strong understanding of regulatory requirements and validation processes.
Proficiency in statistical analysis software and data interpretation.
Excellent problem-solving and communication skills.
Experience with computer system validation and knowledge of GAMP 5.
Familiarity with process validation in a highly regulated industry.
Responsibilities:
Develop and implement validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and processes.
Conduct risk assessments to prioritize validation activities across manufacturing sites.
Ensure compliance with industry regulations and standards, including FDA requirements for dietary supplements and OTC products.
Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to support validation activities.
Maintain and update the Validation Master Plan (VMP) and ensure all validation documentation is accurate and complete.
Troubleshoot and resolve validation-related issues and non-conformances.
Support continuous improvement initiatives by analyzing process data and implementing corrective actions.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
