Key Responsibilities

• Lead Validation Efforts: Oversee the Front End Planning (FEP) for validation deliverables on capital projects, with budgets up to $250 million.
• Collaborate on Design Phases:Work closely with stakeholders, Subject Matter Experts, and vendors to create essential validation documentation, including:
  • 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)
• Define Validation Strategies: Establish effective validation schedules, risk management plans, and strategies in collaboration with Corporate Engineering, Division Quality Assurance, and Site Operations.
• Manage Validation Plans: Develop and execute comprehensive validation plans, working with cross-functional project teams to ensure scope, cost, and schedule controls are maintained.
• Provide Support for Project Controls: Monitor and report on the validation scope, managing any issues and creating compliant solutions.
• Assist with Contingency Planning: Develop and implement plans to address project schedule delays and financial challenges.
• Document and Execute: Support document execution, including Factory Acceptance Tests (FATs) at vendor sites, and provide onsite support during Annual Plant Maintenance (APM).
• Track and Report Hours: Accurately record and report project hours through weekly timesheets.

• Demonstrated experience in validation engineering within Pharmaceutical or Medical Device industries.
• Strong understanding of validation documentation, project management, and risk assessment.
• Excellent communication and collaboration skills, with the ability to work effectively across departments and with external vendors.