Abbott

Senior Validation Engineer - Columbus, OH

Abbott • $78K — $156K *
Columbus, OH 43230In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Science, Engineering, or related field required
  • 5+ years of experience in commissioning, qualification, and validation
  • Expertise in bulk liquid processing, aseptic processing, and related unit operations in food/pharma/nutrition
  • Strong understanding of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP)
  • Proficient in Microsoft Office Suite: Word, Excel, and Outlook

Responsibilities

  • Manage validation programs for Strategic Capacity Expansions
  • Develop and align validation strategies for large-scale capital projects
  • Provide guidance on validation and design control processes
  • Lead internal and external project validation teams
  • Monitor progress and compliance of validation processes
  • Navigate and resolve conflicts between project execution and policy requirements
  • Support resource planning and scheduling for validation

Benefits

  • Health and wellness benefits for you and your family
  • Diverse career opportunities within Abbott
  • Comprehensive training and development support
  • Flexible work arrangements
  • Engagement in a company that values employee well-being
Full Job Description
JOB DESCRIPTION:

Senior Validation Engineer

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.


Apply Now

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.

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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