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Our long-standing Fortune 150 client has engaged us to find  a Sr. Validation Engineer for their rapidly expanding Corporate Engineering team located in Columbus Ohio area to lead validation planning and requirements for numerous large and small capital projects across North American Operations/Plants
    • Develop Front End Planning (FEP) of Validation deliverables for NA capital projects over $1MM up to $250MM
    • Design Qualification (DQ) phase deliverables including User Requirements specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS),Project Validation Plan (PVP) System Impact Assessment (SIA)
    • Facilitate the Risk Management (FMEA) sessions for capital projects
    • Write user requirements to execute validation protocols and supervise 3rd party validation processes
    • Support execution of medium- to large-size projects, requiring custom, risk-managed execution plans, investigations, and/or troubleshooting
    • Maintain project controls and reporting for validation cost and scope; tracks deliverables against the schedule; supports the development of the validation execution strategy with external vendors and project team; balances multiple demands within an assignment, e.g. executes contingency plans to recover from schedule slippage and financial overruns
    • Cultivates internal and external network of Validation resources to complete tasks
    • Provide solutions that are compliant, thorough and practical to a wide range of issues that may arise during validation planning or execution phase
    • Capable of working independently and/ or on project teams, adaptable to a flexible work schedule, willingness to travel
    • Receives little detailed or general direction. Responsible for ensuring compliant documentation in cross functional areas of support
    • Carries out tasks with management guidance; typically, is responsible for decision making. Decisions have long term impact; aligned with the organization strategy

Requirements:

    • Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience
    • At least 5+ years work experience in Quality/Validation, Engineering or related field experience
    • Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred
    • Has experience in regulated industries, with strong understanding of Design Control, Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP)
    • Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence
    • Statistical or Lean Six Sigma background is preferred
                                             Above average salary + PS Bonus+ LTI/pension+ GREAT BENEFITS
                                                            Will provide relocation package as needed
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