Cqv Engineer

4 days ago

Singapore PM Group Full time

**CQV Engineer**:

- Contract
- Singapore, Singapore
- Engineering
- 5070

**Overview
**PM Group Singapore is currently looking to hire a CQV Engineer for our expansion and increased business activities. The incumbent will be involved in Commissioning, Qualification and Validation work within the Pharmaceutical/Life Sciences space. He/She will provide expertise in preparing, reviewing and execution of IQ/PQ/OQ protocols.

**_
This role will be on a 1 year contract with the possibility of extension/renewal._**

**Responsibilities
**Your day-to-day role would involve the following activities**:

- Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc.
- Creation of SOPs or documentation related to the validation activities or maintenance
- Review and approve of validation protocols, reports and deliverables for the specialized validation area
- Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment
- Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
- Creation of Protocols and Reports for Validation Maintenance
- Review and check documentation for GMP compliance
- Collaboration and or Creation of Validation summaries
- Ability to carry out validation activities at least one additional validation areas, e.g. Equipment Qualification, Sterilization In Place, Temperature Controlled Objects (Freezers, Incubator etc), Cleanroom Validation, Clean Utilities Validation (IQ/OQ/PQ/CPV), Cleaning Validation or Process Validation.
- Report/Review validation activity schedule and planning to validation lead, supervisor or manager on a regular basis.
- Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager
- Ongoing feedback of validation status to responsible user
- Perform validation activities and/ or support validation activities
- Ensure validation execution meets compliance, validation standards and cGMP requirements
- Perform validation documentation and/ or support validation documentation in accordance to the division procedures

**Qualifications
Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors.

Experience with temperature mapping is essential. Individuals with Chemical, Biological or comparable technical background

Comes with at least 4 years pharmaceutical work experience or 5 years related regulated environment.

**_
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._

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