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Senior Validation Engineer

Columbus, OH 43219

Posted: 01/26/2023 Employment Type: Contract Job Category: Engineering Job Number: 540253 Is job remote?: No Country: United States

Job Description


FEP / DQ
  • Develop and lead Front End Planning (FEP) of validation deliverables for North America capital projects ranging from $1MM up to $250MM.
  • Will lead the effort with stakeholders, SMEs, and external vendors in Design Qualification (DQ) phase to create the following deliverables, at minimum:
    • Project Validation Plan (PVP)
    • System Impact Assessment (SIA)
    • User Requirements specifications (URS)
    • Functional Requirement Specifications (FRS)
    • Design Specifications (DS)
    • Risk Assessments, such as Failure Mode and Effects Analysis (FMEA)
Execution / Validation Service Provider (VSP) Oversight
  • Participate in multiple, concurrent projects.
  • Establish validation strategies and risk management plans in partnership with Corporate Engineering, Division Quality Assurance and Site Operations.
  • Develop and execute validation plans with support of VSP partners and cross-functional project teams.
  • Maintain project controls and reporting mechanisms for validation scope, cost and schedule of deliverables.
  • Network with others to develop comprehensive and compliant solutions to address issues that may arise during the validation planning or execution phase.
  • Support development and execution of contingency plans to recover from schedule slippage and financial overruns.
Individual Skillset
  • Act as a mentor and coach for a diverse team regarding validation, quality and compliance.
  • Cultivate internal and external network of validation resources to complete tasks.
  • Work independently and/or on project teams, with an ability to support a flexible work schedule and a willingness to travel.
  • Develop validation strategies as part of a cross-functional team in a fluid environment, starting with information of a general nature and refining plans as design progresses.
  • Ensure the development of clear, complete and compliant deliverables that stand up to regulatory scrutiny.
  • Carry out tasks with management guidance, and be able to make data-driven decisions that have long term impact on ability to meet corporate strategies and goals.

EDUCATION AND EXPERIENCE YOU'LL BRING:
Required:
  • Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
  • At least 5 years work experience in Quality, Validation, Engineering or related field.
  • Demonstrated experience in the food industry or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc.
  • Strong understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
  • Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
  • Statistical or Lean Six Sigma background is preferred.
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