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Abbott
Columbus, OH, United States
30+ days ago
Abbott
Columbus, Ohio, United States
30+ days ago

Description

  • The Sr. Principal Validation Engineer provides technical and strategic leadership for Validation, Risk Management, and CAD Services in support of Abbott Nutrition’s North American manufacturing plants.  In collaboration with cross-functional teams, they develop and implement validation plans for capacity improvement projects, cost reductions, and programs for improving reliability/ operational effectiveness of the sites. 
  • Manages a team of Validation and CAD Services professionals responsible for the planning and execution of capital projects within the seven (7) manufacturing sites of North America region.
  • This role requires the creation and execution of strategic initiatives relative to increasing manufacturing capacity, new product introductions, and quality /operational performance improvements in collaboration with plant management leadership teams.
  • Expected to serve as a Validation Subject Matter Expert (SME), engage in strategic technical discussions, and provide cross-functional guidance as appropriate.
  • Manages the requirements associated with Engineering Drawing Management and CAD Services.
  • Responsible for maintaining appropriate staffing levels to ensure workload is fully supported; this may include leveraging of external / contract support.
  • Expected to ensure that all staff are fully trained on Validation and Risk Management policies, regulations, and best practices.
  • Serves as the steward of the Validation Front-End Planning process (FEP) for North America Engineering in accordance with prescribed governance; works to provide continual improvement to this process with cross functional groups.
  • Responsible for facilitating the North America implementation of the Abbott Nutrition Technical Academy in coordination with other leaders within Global Engineering

Project Management: 

  • Provide leadership, oversight and management of Validation planning of over 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
  • Maintain project controls and reporting for validation scope, cost and schedule; track deliverables against schedule; 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 projects; develops and executes contingency plans to recover from schedule slippage and financial overruns.
  • 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, e.g. investigates process to meet increasing regulatory requirements while maintaining manufacturing/construction efficiency.
  • 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 on projects and contracts with external validation service providers
  • Interacts with both senior management and external personnel on significant technical matters often requiring coordination between organizations
  • Prepares written communication
  • 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.
  • Acts as a trusted advisor. Balances bottom line objectives of a project with long-term interest of customer, e.g. makes trade-offs to further the relationship; incorporates long-term customer benefits into project.

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
  • Develops and executes validation protocols
  • Influences validation strategy
  • Provides validation-related training. Represents Abbott Nutrition Engineering Assurance on corporate and division task forces

Position Accountability / Scope:

  • Reports to Director of Regional Engineering
  • 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 within function 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.
  • Develops scenarios to give management a set of viable alternatives; relates risk and gain to critical success factors and recommends action, e.g. evaluates risk/reward ratios and Return-on-Investment (ROI) projections.
  • Decisions or recommendations would typically achieve critical organizational objectives and affect the image of the organization’s technological capability.
  • 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.


Requirements

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

  • Bachelor’s Degree in Engineering, science, or closely related discipline is required.
  • Post-graduate education, degree, or applicable certifications are preferred.
  • 10 yrs. or more experience in related engineering discipline with personnel and project management responsibility.
  • Possesses a strong technical knowledge and application of commissioning and validation concepts, practices, and procedures.
  • Demonstrated experience in the food industry or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc...
  • Demonstrated experience with Root Cause Analysis processes along with a good understanding of relevant technologies and their practical applications.
  • Statistical or Lean Six Sigma background (preferred).

Job Information

  • Job ID: 59231971
  • Location:
    Columbus, Ohio, United States
  • Position Title: Sr. Principal Validation Engineer
  • Company Name: Abbott
  • Industry: Manufacturing/Production
  • Job Function: Engineering
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: Over 10 Years
  • Required Travel: 25-50%
Healthcare / Health Services
Abbott Park , IL , US

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 109,000 colleagues serve people in more than 160 countries.

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