Senior Validation Engineer - Columbus, OH
JOB DESCRIPTION:
Senior Validation Engineer
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.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
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.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
WHAT YOU’LL DO:
As a Senior Validation Engineer, you will:
Manage Validation Program: Oversee the validation program for Strategic Capacity Expansions to ensure the success of large-scale capital projects.
Develop Validation Strategy: Create and align validation strategies for multi-million-dollar capital investments across all design phases.
Provide Guidance: Offer expertise on validation, design control strategies, and changes to products, processes, and equipment.
Team Management: Lead project validation and engineering teams (internal, external, VSPs) to ensure successful execution.
Monitor Progress: Develop metrics to track progress, adherence, and compliance of validation and design control processes; escalate issues as needed.
Navigate Challenges: Resolve conflicts between project execution and policy requirements to achieve compliant outcomes.
Support Resource Planning: Assist PM with validation resource planning, scheduling, and support structure.
Ensure Quality and Compliance: Support the development and delivery of quality, compliant documentation packages on time and cost-effectively.
Policy and Procedure Compliance: Ensure team adherence to policies, processes, and procedures for design control, process validation, and change control.
Cross-Functional Collaboration: Work with Technical, Engineering, Quality, and R&D to implement compliant product/process changes.
Education and Training: Provide visibility and training to ensure proper monitoring of CPPs and compliance with validation and design control regulations.
SME Role: Act as a Subject Matter Expert for validation, design control processes, statistical sampling plans, DOE, and FMEA.
Root Cause Analysis: Collaborate with the team to identify root causes of unexpected outcomes and develop compliant solutions.
Strategic Decision Making: Make strategic decisions for validation encompassing all project phases and resource allocation.
Leadership: Lead a team, ensuring adherence to the Abbott Code of Conduct and maintaining validation competency.
Documentation Oversight: Oversee review and approval of change processes, validation packages, and design control documentation.
Best Practices: Collaborate with corporate, divisional, and capacity expansion teams to utilize and improve validation and design control policies.
Budget Management: Manage the validation budget, ensuring spending within limits and supporting cost-efficient business processes.
Travel: 20-40% travel is expected as part of this role.
EDUCATION AND EXPERIENCE YOU'LL BRING:
Required:
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. Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$78,000.00 - $156,000.00In specific locations, the pay range may vary from the range posted.