About the job
Join AbbVie and make a significant impact in the world of healthcare!
We are currently seeking a Site Process and Cleaning Validation Lead to enhance our dynamic Technical Centre leadership team at AbbVie Westport. This is a permanent role reporting directly to the Director of the Technical Centre.
In this pivotal role, you will oversee and manage the validation of manufacturing processes and cleaning protocols for our products, including eyecare, implants, and biologics such as toxins. You will ensure that all operations meet stringent regulatory standards and internal quality requirements. As the Process and Validation Lead, you will spearhead validation initiatives, collaborate with cross-functional teams, and ensure meticulous documentation and execution of the process and cleaning validation life cycles.
Interested in being part of our team? Read on for more details…
Key Responsibilities:
- Develop and implement comprehensive site validation master plans for both process and cleaning validation.
- Lead the design, planning, and execution of validation protocols, including risk assessments and data analysis during technical transfers.
- Oversee the review and approval processes for validation documentation, reports, and change controls.
- Collaborate with manufacturing, engineering, and quality assurance teams to foster continuous improvement.
- Ensure compliance with global regulatory standards (FDA, EMA, etc.) and internal policies.
- Manage validation investigations, deviation reports, and corrective/preventive actions (CAPAs).
- Train site personnel in validation procedures and best practices.
- Represent the validation function during audits and regulatory inspections.
- Participate in the risk assessment process across all business units and in design review processes.
- Track and generate weekly metrics related to various compliance systems.
- Support audit preparations, direct audit interactions, and responses. Participate in both internal and external audit programs.
- Manage scheduling for revalidation, responses to regulatory inquiries, and laboratory validation documentation in conjunction with Business Unit Owners.
- Coach and develop direct reports to provide technical support and leadership.
- Motivate employees through effective communication and performance review meetings, including individual development plans.
- Maintain staffing levels in line with business needs, including selection and recruitment.
- Develop and manage functional budgets to meet company objectives.