Job Description
Are you an experienced validation professional looking to make a significant impact in the biopharmaceutical industry? Smarthire by SEEK is partnering with a leading life sciences organization in Tuas to recruit a CQV / MSAT Engineer specializing in Process, Cleaning, and SIP (Steam-in-Place) Validation.
In this high-visibility role, you will be instrumental in ensuring that our client's manufacturing processes meet the most stringent regulatory standards. You will bridge the gap between technical MSAT operations and rigorous Quality, Commissioning, and Validation (CQV) requirements, ensuring seamless production and compliance within a fast-paced manufacturing environment.
Responsibilities
- Lead and execute Commissioning, Qualification, and Validation (CQV) activities for biopharmaceutical manufacturing equipment.
- Develop and execute comprehensive validation protocols (IQ/OQ/PQ) for Process, Cleaning, and SIP systems.
- Collaborate with MSAT teams to optimize process parameters and ensure robust lifecycle management.
- Conduct risk assessments and provide technical support for change control and deviation investigations.
- Manage system readiness for audits, ensuring compliance with cGMP, FDA, and EMA guidelines.
- Analyze technical data to provide science-based recommendations for process improvements.
- Coordinate with cross-functional teams to ensure timely completion of project milestones.
Qualifications
- Degree in Chemical Engineering, Biotechnology, or a related field.
- Minimum 3-5 years of experience in CQV/MSAT within the pharmaceutical or biopharma industry.
- In-depth knowledge of Cleaning Validation, SIP, and sterilization processes.
- Solid understanding of cGMP regulations and GAMP 5 validation practices.
- Proven ability to author, review, and approve technical validation documentation.
- Strong analytical problem-solving skills with a high attention to detail.
- Experience in equipment lifecycle management and process validation life cycles.