Cqv Engineer

1 week ago

Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Develop, review and/or approve validation lifecycle document and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
- Take lead and review project design documents (P&IDs, PFDs, URS etc.)
- Define user requirements and create SOPs or documentation related to the validation activities
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Create and review 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
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
- Participate in site Validation Maintenance Program.
- Write execution related deviations and change requests
- Support change implementation on site.
- Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed
- Perform validation documentation and/ or support validation documentation in accordance to the division procedures
- Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager
- Ensure validation execution meets compliance, validation standards and cGMP requirements
- Any other task as assigned by Supervisor/Manager

**About You**:

- Diploma/Degree in Engineering or Science Disciplines with 5 years experience in Pharmaceutical Industry
- Proven track record in **Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)**:

- In-depth knowledge on cGMP, GDP and ASTM E2500
- Proactive and self-motivated
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)
- Effective Project Management, leadership, communication and interpersonal skills

**Job Type**: Contract
Contract length: 6 months

Pay: $5,000.00 - $6,500.00 per month

Schedule:

- Monday to Friday

**Experience**:

- Equipment Qualification: 3 years (preferred)
- HVAC and Utilities Validation (IQ/OQ/PQ/CPV): 4 years (preferred)

Work Location: In person

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