CQV Engineer (Pharma) (SG)

Anter Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Anter Consulting in Singapore is seeking a skilled CQV Engineer to lead commissioning, qualification, and validation activities for a major pharmaceutical project. You will ensure that systems and equipment are properly commissioned, qualified, and validated in accordance with GMP, working closely with engineering, QA, and operations to deliver compliant results.

The role requires a Bachelor’s degree in Engineering or Life Sciences and a minimum of 5 years GMP experience in CQV.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of GMP experience in commissioning, qualification, and validation within the pharmaceutical industry.
• Proficiency in IQ, OQ, and PQ protocols.
• Strong problem-solving, analytical abilities, and attention to detail.
• Excellent communication skills to interact with team members and stakeholders.

Responsibilities

• Oversee the commissioning of pharmaceutical manufacturing equipment and systems to ensure they meet design specifications and regulatory requirements.
• Develop and execute qualification protocols (IQ, OQ, PQ) for equipment, utilities, and systems.
• Ensure that all processes are validated according to industry standards and GMP regulations.
• Prepare and maintain detailed documentation for all commissioning, qualification, and validation activities, including protocols, reports, and traceability matrices.
• Ensure all activities comply with GMP regulations, industry standards, and company policies.
• Work closely with project teams, including engineering, QA, and operations, to ensure seamless integration and project execution.
• Identify and resolve any issues that arise during the commissioning, qualification, and validation processes.
• Provide regular updates and reports to project stakeholders and management on the status of CQV activities.

Skills

GMP experience

CQV

IQ/OQ/PQ protocols

Regulatory compliance

Documentation & traceability

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Job Description

We are seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a significant pharmaceutical project in Singapore. This role involves ensuring that all systems and equipment are properly commissioned, qualified, and validated in compliance with GMP regulations.

Key Responsibilities

• Oversee the commissioning of pharmaceutical manufacturing equipment and systems to ensure they meet design specifications and regulatory requirements.
• Develop and execute qualification protocols (IQ, OQ, PQ) for equipment, utilities, and systems.
• Ensure that all processes are validated according to industry standards and GMP regulations.
• Prepare and maintain detailed documentation for all commissioning, qualification, and validation activities, including protocols, reports, and traceability matrices.
• Ensure all activities comply with GMP regulations, industry standards, and company policies.
• Work closely with project teams, including engineering, QA, and operations, to ensure seamless integration and project execution.
• Identify and resolve any issues that arise during the commissioning, qualification, and validation processes.
• Provide regular updates and reports to project stakeholders and management on the status of CQV activities.

Required Qualifications and Skills

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of GMP experience in commissioning, qualification, and validation within the pharmaceutical industry.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and systems.
• Proficiency in developing and executing IQ, OQ, and PQ protocols.
• Excellent problem-solving and analytical abilities.
• Strong verbal and written communication skills, with the ability to interact effectively with team members and stakeholders.
• High level of accuracy and attention to detail in all aspects of work.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E