Senior CQV Engineer (Pharma/Biotech)

Nusantara Prime Consulting; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A dynamic leader in the pharmaceutical industry is sought to spearhead commissioning, qualification, and validation activities. The role demands extensive experience in Equipment Qualification and a strong understanding of regulatory compliance. Join a dedicated team and contribute to ensuring the highest standards in pharmaceutical processes with competitive remuneration.

Benefits

Health insurance

Qualifications

• At least 5 years of experience in the Pharmaceutical Industry.
• Proven track record in Equipment Qualification for HVAC and Utilities Validation.
• In-depth knowledge of cGMP, GDP, and ASTM E2500.

Responsibilities

• Lead commissioning, qualification, and validation activities for equipment and utilities.
• Generate validation life cycle documentation as per client standards.
• Ensure compliance with cGMP, FDA, EMA, and ASTM E2500 guidelines.

Skills

Project Management

Leadership

Communication

Interpersonal Skills

Education

Diploma/Degree in Engineering or Science

Job description

Full job description

Responsibilities:

• Lead commissioning, qualification, and validation (CQV) activities for equipment, utilities, and process systems.

• Start up and commission various process systems, equipment and utilities.

• Generate and implement validation life cycle documentation such as site acceptance test (SAT), system risk assessment (SRA), design qualification (DQ), installation and operation qualification (IOQ), qualification summary report (QSR) and deviation report for process and utilities equipment as per Client’s standard operation procedure (SOP).

• Ensure validation activities comply with cGMP, FDA, EMA, and ASTM E2500 guidelines.

• Implement approved protocols, identify non-conformances to User Requirements

• Write Requirements Traceability Matrix (RTM) for comments and acquire approval.

• Work closely with a multi-functional team not limiting to operations, QA and engineering.

• Maintain detailed documentation and provide regular updates to stakeholders.

• Write PQ protocols, issue for comments, and acquire pre-execution approval.

• Take lead and review project design documents (P&IDs, PFDs, URS etc.)

• Manage qualification execution and lead validation deviation investigation encountered in qualification.

• Ensure validation execution meets compliance, validation standards and cGMP requirements

• Review and comment pre-execution vendor commissioning protocols. Witness protocol execution. Ensure testing is complete and record test results in accordance with GDP.

• Any other task as assigned by Supervisor/Manager

About You:

• Diploma/Degree in Engineering or Science Disciplines with at least 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: 12 months

Pay: $6,500.00 - $13,000.00 per month

Benefits:

• Health insurance

Schedule:

• Monday to Friday

Experience:

• Equipment Qualification: 5 years (Preferred)

• commissioning, qualification, and validation (CQV): 5 years (Preferred)

• Pharmaceutical Industry : 5 years (Required)

Work Location: In person