This newly created permanent position requires a specialised professional adept in cleaning validation, particularly within biologics manufacturing environments.
This role will join a high performing and state of the art facility where you will have an opportunity to make a noticeable contribution.
Key Responsibilities: Validation Execution: Perform cleaning validation tests as per approved protocols, procedures, and cGMP standards.
Strategy Ownership: Support the development and implementation of the cleaning validation strategy for the site.
Data Analysis & Process Improvement: Analyse validation data and recommend improvements in cleaning and manufacturing processes.
Technical Leadership: Lead investigations for deviations in cleaning validation, including issues related to residues (product, detergent, microbial).
Documentation & Reporting: Write technical evaluations, closure reports, and validation documents such as protocols, deviations, root cause analyses, and impact assessments.
Regulatory Compliance: Ensure alignment with AbbVie and external regulatory and quality compliance standards.
Validation Program Management: Develop and maintain Site Validation Master Plan and Project Validation Plans.
Qualifications & Experience: Degree in engineering or a scientific discipline.
Minimum 3 years in cleaning validation within the biopharmaceutical or sterile manufacturing industries.
Strong understanding of cGMP regulations and compliance.
Exceptional troubleshooting, written, oral, and presentation abilities.
Proven ability to work independently and as part of a collaborative team.
Technical expertise in cleaning validation processes is essential.
Proficient in creating and maintaining validation documentation to cGMP standards.
Skilled in continuous improvement initiatives and team development.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on .
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Skills: Cleaning Validation; Sterile manufacturing technical writing documentation generation