Senior Validation Engineer - Columbus, OH
About The Position
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 122,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help get the nutrients they need to live their healthiest life.
Requirements
- Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
- 5+ years’ experience in commissioning, qualification and validation (preferably with bulk liquid processing, aseptic processing, Clean-In-Place (CIP), evaporation, spray drying, dry blending, and/or powder handling unit operations in the food/pharma/nutrition industries).
- Strong understanding of Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and 21 CFR Part 11.
- Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
Nice To Haves
- Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
Responsibilities
- Oversee the validation program for Strategic Capacity Expansions to ensure the success of large-scale capital projects.
- Create and align validation strategies for multi-million-dollar capital investments across all design phases.
- Offer expertise on validation, design control strategies, and changes to products, processes, and equipment.
- Lead project validation and engineering teams (internal, external, VSPs) to ensure successful execution.
- Develop metrics to track progress, adherence, and compliance of validation and design control processes; escalate issues as needed.
- Resolve conflicts between project execution and policy requirements to achieve compliant outcomes.
- Assist PM with validation resource planning, scheduling, and support structure.
- Support the development and delivery of quality, compliant documentation packages on time and cost-effectively.
- Ensure team adherence to policies, processes, and procedures for design control, process validation, and change control.
- Work with Technical, Engineering, Quality, and R&D to implement compliant product/process changes.
- Provide visibility and training to ensure proper monitoring of CPPs and compliance with validation and design control regulations.
- Act as a Subject Matter Expert for validation, design control processes, statistical sampling plans, DOE, and FMEA.
- Collaborate with the team to identify root causes of unexpected outcomes and develop compliant solutions.
- Make strategic decisions for validation encompassing all project phases and resource allocation.
- Lead a team, ensuring adherence to the Abbott Code of Conduct and maintaining validation competency.
- Oversee review and approval of change processes, validation packages, and design control documentation.
- Collaborate with corporate, divisional, and capacity expansion teams to utilize and improve validation and design control policies.
- Manage the validation budget, ensuring spending within limits and supporting cost-efficient business processes.
- 20-40% travel is expected as part of this role.
Benefits
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
