The Company
Our client is a global biopharmaceutical company committed to advancing innovative medicines that improve patients' lives worldwide. Through cutting-edge research, advanced biologics manufacturing, and a strong focus on quality and innovation, the company delivers life-changing therapies across a wide range of therapeutic areas.
Role Description
As a MSAT Validation Engineer, you will plan, coordinate, and execute validation and qualification activities for biopharmaceutical manufacturing processes, including mixing, sterilization, and buffer/microbial hold time studies. You will ensure GMP compliance by preparing validation documentation, supporting process improvements, and driving performance qualification activities for clinical and commercial drug substance production.
Responsibilities
- Plan, coordinate, and execute validation and qualification activities for biopharmaceutical manufacturing processes.
- Prepare, review, and maintain validation protocols, reports, and GMP-compliant documentation.
- Perform and support sterilization, mixing, and cleaning validation activities to ensure regulatory compliance.
- Collaborate with Operations, Quality, and cross-functional teams to execute validation projects and support change controls.
- Drive process improvements and provide technical support to the MSAT team during validation and qualification activities.
- Ensure all validation activities comply with GMP standards and applicable regulatory guidelines.
Requirements
- Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, or a related Life Sciences field.
- Hands-on experience in validation and/or qualification within a GMP-regulated biopharmaceutical or pharmaceutical environment.
- Strong knowledge of sterilization, mixing, or cleaning validation, along with validation documentation and protocol writing.
- Experience with GMP regulations and pharmaceutical industry guidelines.
- Excellent communication and stakeholder management skills, with the ability to work collaboratively across multidisciplinary teams.
Other Information
Apply to our vacancy for more information. We look forward to hearing from you!
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Ayub Sohail
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