Job Purpose
As the Lead Validation Engineer, you will act as a key Subject Matter Expert driving the site's validation strategy.
You will provide direction, documentation, execution, and oversight for all plant validation activities, ensuring compliance, robustness, and continuous improvement across the facility.
You will work closely with the Validation Manager, lead critical QA functions, and champion the Plant Consumables Programme, making this a highly visible and influential role.
Key Responsibilities
Serve as a core member of the QA Team, reporting to the Validation Manager.
Manage the Validation Change Control System, Validation Master Plan, schedules, and all associated documentation.
Lead the Validation Review Board, ensuring all members are trained and compliant with validation policies and procedures.
Create, review, and approve validation protocols and full validation packages.
Own and manage the Plant Consumables Programme, ensuring compliance and approval of all consumables.
Support CAPA and Quality Metrics programmes.
Conduct compliance audits, walk-downs, and follow-up reporting.
Support QA IT systems (M-Files), including training and developing plant SMEs and users.
Participate in internal audits and support external audit readiness.
Contribute to plant projects and cross-functional initiatives as required.
Adapt to changes in GMP, EHS, Technical, Quality, and SOP updates.
Support QA during internal and external audits, including pre-audit preparation.
Follow all EHS rules, report hazards, and wear appropriate PPE.
Review and adhere to all SOPs relevant to assigned tasks.
Education & Experience
Bachelor's degree in Pharmaceutical Science, Food Science, Dairy Science, Engineering, or a related discipline.
Minimum of 3 years' experience in a Validation role within pharmaceutical, food, healthcare, or regulated manufacturing.
Background in Food Microbiology or Food Chemistry is desirable but not essential.
Key Skills
Strong knowledge of Validation processes, CAPA systems, and FDA/industry regulations.
Advantageous experience in Food Engineering, thermal processing, and fluid flow.
Understanding of manufacturing processes and project management principles.
Excellent interpersonal skills, strong computer literacy, and the ability to work effectively in a high-performance team.
Accountability / Scope
Provide expert leadership in validation direction, documentation, execution, and review.
Ensure validation activities meet regulatory, quality, and operational expectations.
Maintain high standards of accuracy and compliance to protect product quality and plant performance.
Equal Opportunity Employer
Abbott is an equal opportunity employer.
We welcome and encourage the diversity of our workforce and are an affirmative action employer under applicable law.
All positions are assigned on a merit basis and no distinctions will be made based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or other protected status.
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