Validation Engineer 2

• 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

Independently understand client’s quality standards, cGMP’s and regulatory standards to support team in compliance of validation effort. Design validation plans. Conduct independent verification of testing against specifications. Conduct and document impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes. Complete user interface testing, software verification, and complete alarm testing on automated systems. Develop, review, and execute testing documentation. Make recommendations for design or process modification based on test results when executing test scripts. Work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities.  Includes ability to complete root cause analysis. Support clients change management program – including author proposed changes, execute impact assessments/ regression analysis and support client documentation of change results and release. Maintain (and ensure the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.

Bachelor’s degree in Mechanical Engineering or related field (or foreign degree equivalent) and at least 5 years of experience in position involving validation engineering. Alternative Requirements: Employer will also accept a Master’s degree in Mechanical Engineering or related field (or foreign degree equivalent) and 2 years of experience in position involving validation engineering. Required Skills: Demonstrated ability with lab techniques and general lab analytical operations, and understanding of baseline lab standards and system suitability verification; Demonstrated ability with bench top analytical equipment and chromatography and LIMS system sample workflows; Demonstrated ability with IT system formats, configurations, and workflows; Demonstrated ability with business processes supporting one or more domains, such as: R&D, Clinical, Quality System Management, Supply Chain & Logistics or Commercialization; Demonstrated ability with system design and/or configuration activities; Demonstrated ability with complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators; Demonstrated ability with lab system configuration and operation; Demonstrated ability creating various dynamic and static data within a LIMS system; Demonstrated ability with methods and how to acquire, process and report in Empower; Demonstrated ability with system integrations, including how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations; Demonstrated ability providing technical guidance and mentorship to other team members; Demonstrated ability identifying areas of business expansion and report to management team for follow-up.

Reports to Verista, Inc. Headquarters in Fishers, Indiana. Telecommuting permissible from home office anywhere in the U.S. Long term placement at unanticipated client sites in the U.S. possible.