Senior Cqv Engineer

3 days ago

Singapore ANTER CONSULTING PTE. LTD. Full time

**Essential Duties and Responsibilities:
Generates and executes CQV protocols for facilities, utilities, equipment (e.g. Autoclaves, Chambers, Rooms, HVAC, etc.), and computerized systems (e.g. Delta V, HPLCs, Spectrophotometers, etc.).

Performs basic data and statistical analysis (e.g. Temperature, Pressure, etc.).

Generates CQV plans, traceability matrices, and qualification/technical reports.

Generates qualification protocol deviations and non conformances.

Reviews vendor generated computer system qualification protocols/packages.

Generates quality deviations/CAPAs and performs investigations and root cause analysis.

Generates and revises Validation SOPs.

Generates change controls and performs validation expert assessments.

Performs validation risk-assessments.

**Education and/or Experience:
Minimum of 7 years of experience working in a cGMP regulated environment.

Minimum of 7 years of operational validation experience in a cGMP manufacturing environment.

Experience with data acquisition systems (e.g. Kaye Validator, ELLAB, Lives International, etc.)

Experience performing CQV activities for chambers, rooms, autoclaves, bioreactors, utilities (e.g. WFI, Clean Steam, Compressed Air, etc.), HVAC, benchtop laboratory equipment, etc.

**Qualifications:
Previous training on cGMP quality systems such as Change Control, CAPA, and Deviation.

Previous training and practical knowledge of cGMP regulations.

Previous training/knowledge on current risk-based validation approaches.

**Skills**:
Proficient with MS Office Word and Excel.

Excellent oral and written communication and presentation skills.

Good organizational and time management skills.

Ability to manage small projects and tasks with mínimal supervision.

Self-motivated, able to work independently, and work in a team environment.

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