Senior Validation Engineer Columbus, OH

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 122000 colleagues serve people in more than 160 countries.

Senior Validation Engineer

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples looking towards the futureanticipatingchanges in medical science and 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 SimilacPediaSure Pedialyte EnsureandGlucerna 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 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 theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized asa great placeto 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 companywith a record of strong financial performance and history ofbeing actively involved in local communities

WHAT YOULL 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 YOULL BRING:

Required:

• Bachelors 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 FDAs 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:

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 on Facebook at onTwitter @AbbottNewsand @AbbottGlobal.

The base pay for this position is

$78000.00 $156000.00

In specific locations the pay range may vary from the range posted.

Operations Quality

ANSC Nutrition Supply Chain

United States > Columbus : 2900 Easton Square Place

Standard

Yes 25 % of the Time

No

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: EEO is the Law link - Espanol: Experience:

Senior IC