Job Description
This newly created permanent position requires a specialized 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: Analyze 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.
About Us
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