Commissioning, Qualification and Validation Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading consulting firm in Singapore is seeking a CQV Engineer to ensure compliance with pharmaceutical industry standards. The role involves coordinating equipment qualification, providing technical guidance, and developing validation protocols. Candidates should have 4-7 years of experience in a pharmaceutical environment, strong communication skills, and a proactive problem-solving approach. This position emphasizes leadership in maintaining quality and safety standards.

Qualifications

• Minimum of 4–7 years’ relevant experience in a pharmaceutical manufacturing environment.
• Proven ability to multitask and thrive in a fast-paced pharmaceutical setting.
• Continuous improvement mindset with innovative thinking and problem-solving skills.

Responsibilities

• Coordinate and assist with qualification of equipment and utilities.
• Provide technical direction ensuring compliance with pharmaceutical validation.
• Develop, review, and approve validation and qualification protocols.
• Promote a safe and compliant work environment following HSE guidelines.
• Investigate non-conformance issues and ensure timely closure.

Skills

Strong interpersonal and communication skills

Technical expertise in CQV processes

Analytical and problem-solving abilities

Leadership and team management skills

Job description

The CQV (Commissioning, Qualification, and Validation) Engineer will be responsible for ensuring that equipment, utilities, and facilities within the EFU team meet stringent pharmaceutical industry standards and regulatory requirements. This role demands strong technical expertise, leadership, and a continuous improvement mindset to drive compliance, efficiency, and excellence in validation activities in a highly regulated environment.

Key Responsibilities

• Pharmaceutical Equipment & Utilities Qualification: Coordinate and assist with qualification of equipment, utilities, and facility systems, including temperature chamber qualification with temperature mapping, in line with pharmaceutical industry guidelines.
• Technical Guidance & Compliance: Provide technical direction to the team, ensuring strict adherence to pharmaceutical validation requirements for new and modified systems.
• Protocol Development & Execution: Develop, review, and approve validation and qualification protocols. Ensure compliance during execution, address deviations through investigations and corrective actions, and prepare comprehensive summary reports.
• Health, Safety & Environment (HSE): Understand and strictly follow all HSE guidelines, promoting a safe and compliant work environment within pharmaceutical operations.
• Deviation Management: Investigate non-conformance issues (NCRs), ensuring effective resolution and timely closure through corrective actions in line with pharmaceutical quality standards.

Key Performance Indicators (KPIs)

• Ability to lead the team in meeting pharmaceutical validation requirements and ensuring product/process compliance.
• Demonstrated capability to streamline and optimize current pharmaceutical processes.
• Timely completion of assigned activities and tasks in alignment with project plans.
• Achievement of “Right First Time” validation outcomes.

Qualifications & Experience

• Minimum of 4–7 years’ relevant experience in a pharmaceutical manufacturing environment.
• Proven ability to multitask and thrive in a fast-paced pharmaceutical setting with competing priorities.
• Strong interpersonal and communication skills; able to build collaborative relationships with internal and external stakeholders at all levels.
• Excellent team player with a proactive and supportive approach.
• Continuous improvement mindset with innovative thinking and problem-solving skills.

Competencies

• Technical expertise in CQV processes and pharmaceutical regulatory compliance.
• Strong analytical and problem-solving abilities.
• Leadership and team management skills.
• Attention to detail and commitment to quality in pharmaceutical operations.
• Adaptability and resilience in dynamic project environments.