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 113,000 colleagues serve people in more than 160 countries.

Principal 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®, Glucerna® and ZonePerfect® – 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:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 401(k) retirement savings with a generous company match of 5%
• 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

The Opportunity

• This role can accommodate internals in the locations of All US AN Manufacturing Locations and Abbott Park, IL)

The Principal Validation Engineer provides technical and strategic leadership for Validation and Risk Management in Abbott Nutrition, primarily focused on North American site and project support. In collaboration with the global validation and risk management team, in addition to cross-functional partnerships, they perform quality system ownership functions, coach and train site and regional engineering, quality, and system owners in validation principles and execution, support the development and implementation of validation plans for capital project and manufacturing site change control efforts.

Primary Job Functions:

• Lead global community of practice meetings to exchange best practices.
• Develop and track validation related metrics.
• Provide validation training and consultation services on validation policies and practices.
• Work closely with regional engineering and site quality personnel providing expertise and guidance for verifying and validating new products and processes.
• Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.
• Assess validation documentation from DQ through protocol execution from a technical and quality perspective, provide feedback and coaching to improve division-wide validation execution, and escalate potential gaps to leadership
• Provide risk management training and facilitation for FMEA development sessions.
• Review, analyze and provide recommendations for verification and validation test data, including sampling strategy and statistical analysis
• Provide guidance on resolving deviations associated with verification and validation activities.
• Perform quality system owner functions such as procedure and template writing and continuous improvement updates and global CAPA impact assessment at the division and site level
• Attend site and project VRBs to support validation strategy development, protocol review, and provide coaching and feedback to VRB members.

What You’ll Work On

Project Management:

• Provide oversight of validation planning and execution of large-scale capital projects and ensure compliance with Abbott Quality systems and regulatory agencies
• Lead Risk Management activities for new / modified processes associated with capital project execution
• Build strategic partnership between Corporate Engineering, Division Quality Assurance and Site Operations in leading benchmarking efforts to implement Validation policies and best practices
• Support development of validation execution strategy with external vendors and project team
• Mentor and coach diverse team on validation, quality and compliance
• Participate in multiple, concurrent initiatives including strategic quality system improvements as well as time-constrained project or site event support.
• Understands the business needs of the company and has a thorough knowledge of the end customer needs when developing a project scope.

Technical Design / Problem Solving:

• Benchmarks internally/ externally to explore multiple alternative
• Participates in division-wide validation program development and continuous improvement
• Chairs regional technical exchanges to share best practice information.
• Designs and advises on testing strategies and engineering studies, often with multiple variables, and performs detailed analysis
• Structures studies that integrate cross-disciplinary and cross-functional issues to arrive at optimal course of action
• Combines concepts to anticipate or address customer needs; employs proven solutions to increase effectiveness of validation methodology.

Organizational Interface:

• Mentors others by sharing technical expertise and providing feedback and guidance
• Represents the organization as the primary validation contact for site support
• Assesses external validation service providers for suitability and provides onboarding training and coaching in the use of AN templates.
• Interacts with both senior management and external personnel on significant technical and compliance matters often requiring coordination between organizations
• Communicates effectively to varied audiences, tailors communication style and content to ensure message is transmitted effectively to personnel of distinct backgrounds and cross-functional areas
• Conveys information effectively through formal and informal documents, e.g. develops proposals and project summaries
• Exhibits advanced ability to apply concepts of careful communication.
• Follows through on project goals; contributes willingly and incorporates the ideas of others; shares resources, knowledge and accountability to benefit the objectives of the business, e.g. participates in team meetings; serves as functional subject matter expert.
• Builds relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments, e.g. offers assistance; interacts effectively with stakeholders at appropriate levels of the organization.

Additional Responsibilities:

• Coordinates with technical support personnel to conduct experimental qualification runs and engineering studies
• Directs the efforts of others such as technicians and outside resources
• Defines validation strategy
• Provides validation-related training.

Position Accountability / Scope:

• Reports to Global Validation Manager
• Works independently without day-to-day direction.
• Complies with all regulations and standards for Quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott Engineering Standards, and other governance areas as applicable.
• Ensures quality and effectiveness of key results of major projects through sound design, early risk assessments, and implementation of fallback strategies.
• Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.
• Drives functional performance that ensures the highest standards in quality, customer service, and regulatory compliance are met.
• Responsible for implementing and maintaining the effectiveness of the Quality System; failure to adequately perform tasks can result in noncompliance with governmental regulation.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required:

• Bachelor’s Degree in Engineering, science, or closely related discipline is required.
• Engineering degree is preferred

Minimum Experience / Training:

• 10 years or more experience in technical role or design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing desired. Strong preference for infant/adult nutritional manufacturing technical experience.
• Possesses a strong technical knowledge and application of commissioning and validation concepts, practices, and procedures.
• Strong verbal and written communication skills, with technical writing experience and instructor led training experience preferred.
• Demonstrated experience with Failure Mode Effects Analysis and Root Cause Analysis processes along with a good understanding of relevant technologies and their practical applications.
• Statistical or Lean Six Sigma background (preferred).

Apply Now

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.