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Job Description
Validation Engineer Apply Now Applied To save a job sign in or get started
Job ID:
10257445 Posted today Back Charles City, IA, US Engineering Bachelors Degree Full Time, Direct Hire $100,000.00- $130,000.00• Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Charles City, IA, US $100,000.00- $130,000.00• Experienced (Non-Manager) Full Time, Direct Hire Biotechnology/Pharmaceuticals On-site Engineering Bachelors Degree First Shift (Day) Apply Now Applied Job details Validation Engineer (Charles City, Iowa) Our client in the pharmaceutical industry is growing; due to new site development they are adding to their team a Validation Engineer will assist with compliance of validation activities relating to facility and equipment qualifications throughout the plant. Interaction with all areas of the manufacturing plant site will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines.
Responsibilities:
Developing
IQ, OQ, PQ
protocols by utilizing the Company's standardized validation system to ensure consistency. Working to continuously improve/update protocols to meet cGMP requirements. Coordinating equipment and facility qualification activities between Engineering, Maintenance, QA, Operations, construction firms, and validation contractors. Coordinating with Maintenance to repair system failures. Maintaining validated systems as required by change control. Performing small validation studies. Driving revalidation efforts to ensure systems continue to meet regulatory requirements. Performing or overseeing execution of protocols, including gathering IQ documentation, resolving exceptional conditions, preparing final qualification reports, etc. Defending qualifications during FDA and customer audits.
Qualifications/Skills:
Knowledge of cGMP equipment and manufacturing operations. Demonstrated proficiency in windows-based environment including word processing, spreadsheet, and data base programs. Desire to work with or knowledge of Distributive Control Systems. Education, Experience & Licensing Requirements BS Chemical Engineering or other Engineering discipline preferred. 5 or more years of experience in a CDMO, pharmaceutical/biotech manufacturer, API manufacturing and/or pilot plant environment highly preferred. Client is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. they are one of the most trusted partners worldwide in branded and generic markets for API and dosage form development and manufacturing. 10257445 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.
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