C&Q Engineer - JL

C&Q Engineer (1-year renewable contract)

Background

Our client is seeking experienced Commissioning, Qualification and Validation (CQV) professionals to support a major pharmaceutical manufacturing project in Tuas Biomedical Park, Singapore.

The project involves the development of a new end-to-end manufacturing facility for Antibody Drug Conjugates (ADC) on a greenfield site. The successful candidate will support the C&Q team in ensuring that facilities, equipment, utilities and systems are commissioned, qualified and documented in accordance with project requirements and Good Manufacturing Practice (GMP) standards.

Key Responsibilities

• Support the C&Q Manager and Compliance Lead in planning and executing commissioning and qualification activities across assigned areas or systems.
• Develop and implement C&Q strategies, plans and procedures in accordance with project requirements, GMP standards and applicable guidelines.
• Prepare, review and coordinate C&Q documentation, including commissioning plans, qualification protocols, validation plans, reports and supporting records.
• Support the execution and review of IQ/OQ/PQ and other qualification and validation activities for pharmaceutical equipment, utilities and facilities.
• Conduct and support risk assessments, impact assessments and other activities required for risk-based validation.
• Coordinate with Engineering, QA, Operations, EHS, CQV, IT and other project stakeholders to align C&Q strategies, deliverables and timelines.
• Liaise with EPCM partners, contractors, equipment vendors, suppliers and engineering consultants to coordinate C&Q activities and resolve technical or documentation issues.
• Support C&Q schedule tracking and ensure assigned deliverables are completed within agreed timelines.
• Lead or participate in C&Q meetings to review progress, address issues and align execution strategies.
• Support deviation investigations, change controls, CAPA and other quality-related activities arising from C&Q execution.
• Ensure C&Q activities and documentation comply with GMP, company quality standards and applicable regulatory requirements.
• Support the implementation and use of digital C&Q/validation platforms such as Kneat, Veeva or ValGenesis.
• Contribute to audit and inspection readiness by ensuring C&Q documentation is complete, accurate, traceable and maintained to the required quality standards.
• Provide support to other C&Q workstreams or leads on project-specific commissioning, qualification and compliance activities as required.

Requirements

• Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Science, Chemistry or a related technical discipline.
• Relevant experience in Commissioning, Qualification and Validation (CQV), validation, commissioning or pharmaceutical manufacturing projects.
• Experience working in a GMP/cGMP-regulated pharmaceutical or biopharmaceutical environment.
• Practical experience with qualification and validation activities, such as IQ, OQ, PQ, DQ, FAT/SAT or process/equipment validation.
• Knowledge of risk-based validation principles and relevant GMP/regulatory requirements.
• Experience with C&Q or validation documentation and quality systems.
• Familiarity with digital validation platforms such as Kneat, Veeva Vault, ValGenesis or similar systems will be an advantage.
• Strong communication, coordination and stakeholder management skills, with the ability to work effectively with internal teams, contractors and external vendors.
• Ability to manage multiple priorities and work within project timelines.

Preferred Experience

• Experience supporting greenfield pharmaceutical or biopharmaceutical facility projects.
• Experience working with EPCM companies, engineering consultants, equipment vendors or contractors.
• Experience in deviation investigation, CAPA, change control and audit/inspection readiness.
• PMP or equivalent project management certification will be an advantage

We regret to inform that only shortlisted candidates are notified.

Justin Lee
Registration No.: R22107715
APBA TG Human Resource Pte Ltd
EA Licence No.: 14C7275