Validation Engineer - Sturgis, MI Plant
About The Position
The Validation Engineer works at Abbott’s Sturgis, Michigan location in the Abbott Nutrition division. The role leads and maintains a compliant site validation program that meets regulatory, corporate, and quality requirements. It supports product transfers, process improvements, cost-reduction initiatives, capital projects, and other validation-related work. As a validation subject matter expert, the engineer guides internal stakeholders and project teams, assesses the site impact of policy changes, and coordinates training for employees, approvers, and Validation Review Board members. The role oversees validation documentation and electronic workflows in M-Files; maintains validation master plans, matrices, periodic reviews, and gap remediation; leads validation personnel and Validation Review Board activities; and reviews and approves validation protocols. The engineer also supports internal and external audits and represents the site in validation communities of practice and cross-functional forums. The role is accountable for compliance with FDA and OSHA requirements and Abbott policies and procedures.
Requirements
- Bachelor of Science in Engineering; Chemical, Biomedical, Mechanical, Industrial, Electrical, or Manufacturing Engineering is preferred.
Nice To Haves
- Experience with validation programs in a regulated manufacturing environment, such as medical device, pharmaceutical, or a related industry.
- Knowledge of validation lifecycle activities, including IQ/OQ/PQ, risk assessments, and change management.
- Experience with electronic document management systems such as M-Files and with supporting regulatory audits and inspections.
Responsibilities
- Manage and maintain a site validation program that complies with regulatory, corporate, and quality requirements.
- Ensure validation procedures align with corporate policies and support ongoing site compliance.
- Provide validation support for product transfers, process improvements, cost-reduction initiatives, and capital projects.
- Serve as a validation subject matter expert and guide internal stakeholders and project teams.
- Review validation-related policy changes and assess their impact on the site.
- Coordinate and deliver validation training for employees, approvers, and Validation Review Board members.
- Oversee validation documentation, tracking, approvals, and electronic workflows through M-Files.
- Maintain validation master plans and matrices, conduct periodic reviews, and remediate validation gaps.
- Lead validation personnel, facilitate Validation Review Board activities, and review and approve validation protocols.
- Support internal and external audits and represent the site in validation communities of practice and cross-functional forums.
- Meet compliance standards, including FDA and OSHA requirements and Abbott policies and procedures.
Benefits
- Clean, well-lit, temperature-controlled production areas.
- Training and career development, onboarding programs, and tuition assistance.
- Competitive compensation, incentives, and a retirement plan.
- Medical, dental, and vision coverage, wellness and occupational health programs; medical benefits start on day one.
- 120 hours of accrued vacation in the first year, prorated as applicable, a vacation buy program, three personal days, and ten paid holidays.
- Retiree Healthcare program.
- 401(k) retirement savings plan with a company match.
- Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
- Free coverage in the HIP PPO medical plan in the next calendar year for participants who complete a short wellness assessment.
