Senior Validation Engineer - Wedgewood Village Pharmacy, LLC : Job Details

Job Description:

• Perform Commissioning, Qualification, Validation and Re-validation activities on Equipment, Utilities, and Facility used in the Pharmaceutical Drug Manufacturing and Quality Testing in FDA approved CGMP facilities.
• Draft and review Validation Life Cycle documentation for Equipment, Utilities and Facility such as Qualification protocols [Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualifications (PQ)], Specification documents such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Specifications (SS); Validation Summary reports, Deviations reports, Periodic Reviews.
• Author and review Standard Operating Procedures for operation of Validation supporting equipment using Kaye Validator, Smogger and LogTags.
• Author Traceability matrix and performing functional risk assessments for GMP critical requirements.
• Perform re-qualification of equipment and facilities as required.
• Participate in investigation and for deviations impacting quality, safety, and productivity requirements.
• Create, populate, and maintain databases for tracking validation activities, test results, and validate systems.
• Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities.
• Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types.

Education and Experience required:

• Master's degree or equivalent in Chemical Engineering, Pharmaceutical Engineering or a related field plus 2 years experience in job offered or as or Engineer.
• In lieu of Master's degree and 2 year's experience will accept Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering or a related field plus 5 years progressive experience in job offered or as Engineer.
• Prior work experience must include 2 years experience using Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualifications (PQ), Kaye Validator, Smogger and LogTags, Validation Summary reports, Deviations reports.

Mail resume to HR Manager, c/o Wedgewood Village Pharmacy, LLC, 405 Heron Dr, Suite 200, Swedesboro, NJ 08085. Ref: WVP- 1 Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.