CQV Engineer (Pharma) (SG)

Anter Consulting; Singapore; On-site; SGD 55,000 - 75,000; Full time

Job summary

Anter Consulting is seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a significant pharmaceutical project in Singapore. The selected candidate will oversee the commissioning of pharmaceutical manufacturing equipment, ensuring all systems comply with regulatory requirements and GMP standards.

The role requires a Bachelor's degree in Engineering or Life Sciences and a minimum of 5 years of GMP experience. Strong analytical skills and attention to detail are crucial for success in maintaining compliance and ensuring seamless project execution.

Qualifications

• Bachelor's degree is required.
• Minimum of 5 years of GMP experience in the pharmaceutical industry.
• Strong understanding of pharmaceutical processes and equipment.

Responsibilities

• Oversee commissioning of pharmaceutical equipment and systems.
• Develop and execute qualification protocols for systems and utilities.
• Ensure all processes comply with GMP regulations.

Skills

GMP experience

Pharmaceutical manufacturing

Protocol development (IQ, OQ, PQ)

Analytical abilities

Communication skills

Attention to detail

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.