Abbott Validation Engineer - Sturgis Plant in Sturgis, Michigan
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 107,000 colleagues serve people in more than 160 countries
Nourish the world and your career as part of the Nutrition team at Abbott.
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.
Abbott’s Sturgis, Michigan. , location is an award-winning nutrition manufacturing plant, which recently celebrated its 70th anniversary as part of the community. Working here, you’ll feel part of a family – a family of 400 that works together to help nourish the world.
WHAT YOU’LL DO
Manage an efficient validation program that is compliant to regulatory and corporate quality guidelines.
Interfaces with corporate representatives to insure that site validation program/procedures are reflective of such policies and guidelines.
Review and assess policy changes as they are developed by Division and provide site impact prior to policy approval.
Complete training for change owners, reviewers and approvers according to the training guidelines of the Division Validation Policies and M-files Procedures.
Ensure the VRB members are adequately trained in validation policies.
Track validation packages throughout the validation cycle. Assure proposed validation packages and reviewed and submitted in a timely fashion and assure a reasonable period of time after the validation work is completed before the documentation is completed
Maintain documentation of the names and disciplines of the VRB and their designate members authorized to review and approve validation documentation.
Conduct annual Periodic Review for the Sturgis Direct Impact subject and systems.
Serve as site M-files SME for internal clients.
Manage electronic Validation Tracking and Approval process via M-files.
Assures that the site is operating in compliance to site validation procedures.
Support validation activities associated with product transfers, process improvements, and cost reduction projects.
Provide guidance on validation approach to internal customers.
Provide validation assessments and potential impacts for capital projects as part of the Capital Plan development.
Maintain the site validation master plan/validation matrices and revise as required.
Identify validation gaps and remediate as necessary.
Direct the activities of the validation administrator and validation engineers. Provide guidance/training on validation approach to staff and internal customers.
Oversee the validation review board and facilitate resolution of validation issues.
Review and approve validation protocols.
Provide Validation Support, as required, for all internal and external audits.
Support Validation COP meeting. Represent Sturgis Plant is these forums and provide feedback from the COP to Engineering and Quality teams
You’ll also be accountable for providing excellent customer service to the production teams and meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors of Science degree in Engineering or equivalent experience
3 - 5 years’ experience with validation activities in a GMP environment, which includes qualification of manufacturing process systems, utilities, facilities and support equipment
- Work experience in the food / medical industry under FDA regulation preferred.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit and temperature-controlled
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
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org
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