Cqv Engineer
3 days ago
6 years exp
**Roles & Responsibilities**
Due to the current demand with PM Group's expertise and successful project delivery, we are currently looking to expand our CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work. within the Life Sciences space.
**Your day to day role would involve the following activities**:
- Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
- The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
- Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Can lead investigation revolving around discrepancies identified during qualification activities.
- Experience in coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
- Experience in leading daily validation meetings with cross functional in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
- Work experience in Pharmaceutical, BioPharma or Food industries
- Hands on validation execution experience
- Review validation documents
- Write validation protocols and reports
- Able to execute activities in cGMP environment, including cleanrooms or technical areas.
- Good command of English
- Attention to details
**_
Equal Opportunity Policy_**
**_
PM Group is committed to equality of opportunity for all job applicants and selects those suitable for employment on the basis of merit, qualifications and ability to perform the job._**
PM Group Singapore
PM Group is an employee owned, international project delivery firm. Our team of 2,800 people manage the design, construction and commissioning of high-tech facilities.
At PM Group, we work hard to make your career satisfying and rewarding. We’re employee owned and this means we are hugely committed to our clients and to the people who work with us. We’re not just interested in building your career, we invest in making it happen. We design and deliver some of the most interesting and challenging projects for the world's leading companies. So if you are looking for your next challenge, check out the great roles we have on offer.
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