Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Primary Function / Primary Goals / Objectives:
The Validation QA Section Manager will provide functional leadership and direction to Abbott Nutrition (AN) Innovation teams. This position will support Abbott Nutrition’s divisional Validation program and provide QA guidance on process, test method, equipment and product validation, to ensure that compliance with global Validation regulations and Good Engineering Practices (GEPs) is achieved in the most productive and cost effective manner. The incumbent will support AN’s Validation and Calibration programs, provide input and direction during the New Product Introduction (NPI)process, and implement solutions that have significant impact on regulatory and GEP compliance. The skill set of the position requires a balance of quality and engineering principles, design control principles, process improvement techniques, and regulatory compliance.
Accountability / Scope:
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Support Validation (process, test method and product) and Calibration programs compliant with Corporate and Division policy and consistent with strategic and tactical plans.
- Provide Quality Engineering support to Innovation projects in the areas of Validation Master Planning, Test Plans, and associated acceptance criteria.
- Assess site manufacturing and testing activities and the application of GEPs for Innovation projects supported.
- Ensure adequate impact assessments to existing test method, process (including cleaning), software and product validations are conducted when new products and/or changes to existing products are introduced.
- Design and deliver Validation training for new product development project teams, Division Engineering, Global Plant Engineering, Quality Engineering and external engineering service providers, as needed.
- Support the analysis, and recommendation of solutions to process engineering challenges tied to Validation compliance and/or Facilities, Utilities, Equipment (F/U/E).
- Network with peers to assure Innovation project alignment and execution with industry Validation requirements and GEP standards.
- Review and provide input on division Validation (including test method and software) and Calibration procedures, templates, etc.
- Evaluate current Engineering business processes (e.g., project implementation, technology transfer) for quality improvements. Provide input, update and consolidate Quality Engineering information and tools.
- Review Test Method Validation package deliverables, as necessary, and provide support to division Laboratory Manager.
The position reports to Manager, Global Product Technology in Design Assurance. The incumbent is responsible for ensuring Innovation projects comply with global and regional regulatory requirements, Corporate and Division Validation / Calibration policies and GEP standards. The position relies heavily on the incumbent to operate proactively and independently in performing the job duties. The success of the position relies heavily on the ability to influence other groups to implement compliant and quality outcomes that support business strategy and aggressive project timelines. Failure to provide an effective Validation strategy and/or to meet requirements can result in regulatory non-compliance issues, project delays, costly operations failures and associated product destruct.
Position can be located in either Columbus, OH or Lake County, IL
A minimum of 5-7 years of experience in Quality (validation QA preferable), Product Development, Engineering or Manufacturing is required. Experience working with cross functional and global teams is required.
The position requires a Bachelor’s degree, preferably in an Engineering, science, or closely related discipline. Equivalent experience will be considered. Advanced degree and/or professional certification (e.g., ASQ) is preferable.
The incumbent will act as an independent technical expert and consultant in the areas of F/U/E Validation (including software) and Calibration, and will provide influence to Division and Corporate policy. S/he must have professional experience and demonstrated success in Validation / Commissioning / Calibration execution (e.g., process, cleaning, equipment, test method, software). The incumbent must be self-directed, work well in a team environment, and be able to work on multiple projects simultaneously. The position provides support to multiple AN facilities within and outside the US. International experience is a plus. S/he should have demonstrated oral and written communication skills, and be able to analyze/present data to Engineering, Quality and management functions, as needed.
No relocation assistance will be provided.
Position location open to either Chicago, IL or Columbus, OH.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
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