Principal Validation Engineer- Columbus, OH - Candidate Pipeline

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Providing Division Engineering Validation support as a Subject matter Expert to Abbott Manufacturing Sites and Division Engineering. Strong Commissioning, Qualification and Validation experience in the following areas: Facilities/HVAC, Utilities, Equipment and Automation systems

Responsibilities:

• Lead Front End Planning (FEP) of Validation deliverables for NA capital projects over $1MM
• Responsible to develop the following FEP deliverables for NA capital projects over $1MM
  • 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
• 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
• 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
• pays attention to detail, perform critical analysis of situations and provide recommendations, familiar) and cGMP environment

Position Accountability/Scope

• 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

Minimum Education

• Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience

Minimum Experience / Training Required

• At least 8 years work experience in Quality, Engineering or related filed experience
• Has experience in regulated industries, with good documentation practices (GDP) and current Good Manufacturing Practices (cGMP)
• Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence

JOB FAMILY:

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