Sr. Validation Engineer

Abbott Laboratories • Columbus, OH

409d • $95,000 - $190,000

About The Position

The Senior Validation Engineer at Abbott plays a crucial role in managing the validation program for strategic capacity expansions, ensuring the success of large-scale capital projects. This position involves developing validation strategies, providing guidance on validation and design control, and leading project teams to ensure compliance and quality in documentation. The role requires collaboration across various departments and strategic decision-making to navigate challenges and maintain adherence to policies and procedures.

Requirements

• Bachelor's degree in Life Science, Engineering, or closely related discipline.
• 5+ years' experience in commissioning, qualification and validation, preferably in 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 is preferred.
• Proficient with Microsoft Word, Excel, and Outlook.

Nice To Haves

• Experience with bulk liquid processing, aseptic processing, Clean-In-Place (CIP), evaporation, spray drying, dry blending, and/or powder handling unit operations.

Responsibilities

• Oversee the validation program for Strategic Capacity Expansions.
• Create and align validation strategies for multi-million-dollar capital investments.
• Offer expertise on validation, design control strategies, and changes to products, processes, and equipment.
• Lead project validation and engineering teams to ensure successful execution.
• Develop metrics to track progress, adherence, and compliance of validation and design control processes.
• Resolve conflicts between project execution and policy requirements.
• Assist PM with validation resource planning, scheduling, and support structure.
• Support the development and delivery of quality, compliant documentation packages.
• 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 and design control processes.
• 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.

Benefits

• Competitive compensation and incentives
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• Training and career development with onboarding programs and tuition assistance
• A fast-paced work environment where safety is a priority
• Clean, well-lit, and temperature-controlled production areas

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees