PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Commissioning, Qualification and Validation (CQV) Engineer with experience in pharmaceutical company/Life Science industries for a role in Singapore.

EQUIPMENT & SYSTEMS QUALIFICATION

• Collaborate with Quality Control (QC) Subject Matter Experts (SMEs) to capture and align user requirements for the qualification of new laboratory and production equipment.
• Participate in risk assessments and define qualification strategies in alignment with project and regulatory requirements.

QUALIFICATIONS & SKILLS:

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Experience in Commissioning, Qualification, and Validation (CQV) in a regulated (GMP) pharmaceutical/biopharma environment.
• Knowledge of regulatory guidelines (FDA, EMA, ICH, ISPE, GAMP 5).
• Strong technical writing, analytical, and problem-solving skills.Excellent coordination, communication, and stakeholder management abilities.