Senior Validation Engineer - Columbus, OH

Abbott Laboratories; Columbus (OH); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health Insurance

Excellent retirement plan

Tuition reimbursement

Free education benefits

Job summary

Abbott is seeking a Senior Validation Engineer to lead the validation program for strategic capacity expansions and to shape validation strategies for multi-million-dollar capital investments. You will guide design control, processes, and equipment changes while leading internal and external teams to ensure compliant execution.

The role requires 5+ years in commissioning, qualification, and validation within the pharma/nutrition space, with GDP, cGMP knowledge. Travel of 20–40% is expected.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline required.
• 5+ years’ experience in commissioning, qualification and validation in food/pharma/nutrition industries.
• Familiarity with GDP, cGMP and 21 CFR Part 11; GAMP5 and FDA Computer Software Assurance preferred.

Responsibilities

• Oversee the validation program for Strategic Capacity Expansions to ensure success of large-scale capital projects.
• Create and align validation strategies for multi-million-dollar capital investments across all design phases.
• Lead project validation and engineering teams to ensure successful execution.
• Develop metrics to track progress, adherence, and compliance of validation and design control processes.

Skills

Leadership

Project management

Education

Bachelor’s degree in Life Science/Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

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 122,000 colleagues serve people in more than 160 countries.

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:

• 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.

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Columbus : 2900 Easton Square Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

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