Csv Engineer

1 week ago

Singapore No deviation Pte Ltd Full time

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.

We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.

**Scope and Responsibilities**:

- Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
- Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
- Create and modify validation documentation including but not limited to:

- User Requirements Specifications (URS)
- Design Reviews (DR)
- Criticality assessments
- CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
- Reports which summarize the results of the protocol executions
- Exception reports which identify defects or issues during test execution
- Review vendor documentation
- Continuous improvement on validation process and procedure
- Assist or coordinate generation of Standard Operating Procedures (SOPs)
- Follow the proper site safety practices; wearing adequate safety equipment when required

**Qualifications**:

- Degree in Engineering or Science discipline. Preferably in Electrical Engineering, Computer Science/Information Technology, or Chemical/Biochemical/Mechanical Engineering.
- Minimum 5 years of experience in Pharmaceutical Industry doing CSV related roles
- Experience in validating digitalization systems (Virtual Reality, Augmented Reality, Process Analytical Technology, Material Tracking and Biometric Identification System)
- Proven track record in promoting safety practices.
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management colleagues.
- Proactive, self-starter and capable of working alone or in a team environment.
- Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
- Previous DCS (DeltaV), WinCC, SIEMENS and Rockwell automation systems testing experience required
- Experienced in developing automation protocols
- Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines
- Knowledge of ASTM 2500E risk-based approaches
- To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
- Experience with Quality Change Control is desirable

EA License No : 19C9587

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