Site Process and Cleaning Validation Lead

If you want to be a difference maker our people are waiting. See the difference you can make at AbbVie.

We are now looking for a Site Process and Cleaning Validation Lead to join our diverse Technical Centre leadership team at AbbVie Westport on a permanent basis reporting into the Director of Technical Centre.

In this role you will be responsible for managing and overseeing the validation of manufacturing processes and cleaning procedures at the site (for eyecare implants and biologics including toxins) to ensure compliance with regulatory standards and internal quality requirements. As our new Process and Validation lead you will lead validation activities partner with cross-functional teams and ensures robust documentation and execution of process and cleaning validation life cycles.

Is this a team you want to be part of Then read on

Key Responsibilities:

• Develop and execute site validation master plans for process and cleaning validation.
• Lead the design planning and implementation of validation protocols (PPQ) including risk assessments and data analysis during tech transfer.
• Oversee the review and approval of validation documentation reports and change controls.
• Collaborate with manufacturing engineering and quality assurance teams to drive continuous improvement.
• Ensure compliance with global regulatory requirements (FDA EMA etc.) and company policies.
• Manage validation investigations deviation reports and corrective/preventive actions (CAPAs).
• Train site personnel on validation procedures and best practices.
• Represent validation function in audits and regulatory inspections.
• Participate in risk assessment process for all business units & Participate in design review process for all business units.
• Tracking and generation of weekly metrics (GTW QMS EHS Compliance Wire etc.)
• Provide support for audit preparation direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review).
• Manage revalidation schedule regulatory affairs response laboratory validation documentation review and APR report in conjunction with Business Unit Owner.
• Coach and Develop (including upskilling as required) direct reports to ensure provision of technical support/leadership to the site.
• Manage and motivate the employees in the function through effective communication to the management positions and their reports.
• Hold performance review meetings according to company policy including individual development plans.
• Maintain staffing in line with business needs including selection and recruitment.
• Develop and manage the functional budgets to meet company objectives.
• Manage non-conforming KPIs as required by putting in place robust preventative action plans.

Qualifications :

So what do you need to excel in this role

Qualifications Technical Skills and Experience:

• 9 Years (Bachelors) or 7 years (Masters) or 5 years (Phd) degree in a scientific or engineering discipline (Chemistry Microbiology Pharmacy Chemical Engineering or related field).
• 7 years of experience in pharmaceutical validation (process and/or cleaning).
• In-depth knowledge of regulatory guidelines for validation (cGMP FDA EMA ICH Q7/Q8/Q9/Q10).
• Strong project management problem-solving and organizational skills.
• Ability to work collaboratively in a cross-functional environment and manage multiple projects simultaneously.
• Excellent conflict handling skills
• Expertise in the relevant subject matter areas example cleaning CSV Aseptics process CPV
• Understanding of Process Validation Computer system Validation SCADA systems CPV Sterilization Packaging systems and related technologies.
• A strong understanding of current data integrity expectations would be a distinct advantage.
• Excellent communication and presentations skills both written and oral ability to present data in a clear and concise manner to team members and where required to management

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time