Senior Validation Engineer
Columbus, OH 43219 US
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)
- 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.
- 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:
- 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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