CSV Specialist III

The CSV Specialist Level 3 helps lead team members in assessing new and changing computerized systems to ensure compliance with company policies, procedures, and industry guidance. The role is responsible for risk assessing systems, reviewing change requests and test scripts, drafting protocols, initiating and reviewing GMP documentation revisions, and providing guidance to junior team members. The specialist will also serve as the QA CSV representative during small and large-scale projects for the client. Responsibilities

• Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
• Execute all responsibilities as CSV Project Lead for simple projects.
• Oversee and perform all CSV qualification activities for DeltaV and Syncade systems.
• Perform validation maintenance of computerized systems.
• Review and revise CSV SOPs.
• Review engineering documents, including P&IDs, SOPs, Specifications, and Submittals.
• Assist with audits and inspections.
• Perform other duties as assigned.
• Adhere to cGMP requirements at all times during the manufacture of drug products.
• Notify responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects, and related actions.
• Follow job safety procedures and attend required health and safety training.
• Proactively promote workplace safety and promptly report actual and potential accidents and injuries.
• Comply with company and site safety policies., Position: Computer User Support Specialist Location: Norfolk, 100% on-site Shift hours: 11:20pm - 7:50am (Overnight shift) Clearance: Top Secret (with SCI eligibility) Comp…
• 1 month ago +

• Bachelor’s Degree in Computer Science, Software Engineering, or a related field.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
• Experience with QMS processes, including Change Control, Deviations, and CAPAs.
• Experience performing CSV qualification activities for DeltaV and Syncade systems.
• Experience with validation maintenance of computerized systems.
• Ability to review and revise CSV SOPs.
• Experience reviewing engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.).
• Strong written and oral communication skills.
• Strong organizational and time management skills.

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy., TekWissen Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.