Lab CSV Engineer (Pharma) (SG)
Date Posted: August 29, 2024
Job Description
We are seeking a highly skilled Lab CSV (Computer System Validation) Engineer to join our team for a significant pharmaceutical project in Singapore. This role involves ensuring that all laboratory equipment and systems are validated, compliant with industry standards, and operate with high reliability.
Key Responsibilities
- Create and implement comprehensive validation plans for laboratory equipment, ensuring adherence to GMP, GLP, FDA, EMA, and other regulatory standards.
- Conduct thorough risk assessments to identify and mitigate operational and compliance risks associated with lab equipment and systems.
- Design and execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for various laboratory instruments such as HPLCs, GCs, spectrophotometers, and automated systems.
- Maintain detailed and accurate documentation of all validation activities, including test protocols, results, and compliance records.
- Work closely with quality assurance (QA), engineering, and laboratory teams to drive document approvals and ensure seamless integration and operation of lab systems.
- Coordinate the delivery of project milestones and system handovers, ensuring all activities are completed on time and meet project specifications.
- Ensure all validation activities comply with local and international regulations, industry standards, and company policies.
- Identify opportunities for improving validation processes and implement best practices to enhance efficiency and compliance.
Required Qualifications and Skills
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Minimum of 5 years of experience in CSV (Computer System Validation) within the pharmaceutical or biotech industry.
- In-depth understanding of GMP, GLP, FDA, EMA regulations, and industry best practices.
- Proficiency in validation of laboratory equipment, including HPLCs, GCs, spectrophotometers, and automated systems.
- Strong ability to conduct risk assessments and develop mitigation strategies.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional teams.
- High attention to detail, ensuring accuracy and compliance in all validation activities.
- Strong troubleshooting and problem-solving skills to address and resolve validation issues.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E