6546- Senior CSV Engineer / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

We're looking for a Senior Validation Engineer with deep CSV experience. You'll design and carry out validation activities on your own, in line with regulations and quality requirements. You'll give technical guidance to other team members, work directly with clients, and potentially support more than one project at a time.

• →Design validation plans and strategies for GxP computerized systems, including enterprise, lab, and IT systems
• →Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports
• →Run impact and risk assessments with a full understanding of how the system works, and classify systems and functions as direct, indirect, or no impact
• →Independently verify testing against specifications, and make recommendations for design or process changes based on test results
• →Work with the client's quality representatives on deviation investigations, root cause analysis, and resolution
• →Support the client's change management program by authoring proposed changes, running impact and regression assessments, and documenting change results and release
• →Evaluate system integrations: how they're designed and built, how data flows from source to target systems, and how to test them
• →Keep clear, detailed records of qualification, validation, and change control activities so they're ready for future audits, and make sure the team does the same
• →Mentor and guide less experienced team members
• →Communicate requirements, with the reasoning behind them, clearly in writing and in person to all levels of the client's organization
• →Spot opportunities to expand the business and pass them to management for follow-up

• Bachelor's degree or equivalent
• MINIMUM of 4–6 years of CSV specific validation experience in the pharmaceutical, biotech, or medical device industry
• A track record of producing CSV deliverables independently in a cGxP-regulated environment
• Strong knowledge of cGMPs, Good Documentation Practices, and regulatory expectations for computerized systems (such as 21 CFR Part 11, EU Annex 11, and GAMP 5)
• Hands-on experience with system design and/or configuration, and familiarity with business processes in areas such as R&D, Clinical, Quality Systems, Supply Chain, or Commercialization
• Experience with lab systems (LIMS, Empower/CDS, HPLC, GC) is a plus
• Advanced Microsoft Word, Excel, and PowerPoint skills. Intermediate Microsoft Project skills
• Professional maturity, strong interpersonal skills, and good judgment. You can set your own priorities and make sound decisions on your own
• Strong problem-solving skills, attention to detail, and organization
• Digital Validation experience preferred