Cqv Engineer for Quality Control

1 week ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

**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 for Quality Control with experience in pharmaceutical company/Life Science industries for a role in Singapore.

**Key Responsibilities**:

- Drafting and execution of Commissioning and Qualification documents such as Qualification Plans, Commissioning Qualification Protocols, Data integrity Assessments/ Security Assessments and Qualification Summary reports.
- Coordination with QC Subject Matter experts on user requirements for qualification of new equipment
- Vendor coordination, review of vendor IOQs and coordinate equipment installation, testing.
- Ensure compliance with GMP and applicable regulatory requirements
- Conduct risk assessments and support change control, deviation investigation, and corrective action processes related to equipment qualification.
- Maintain accurate and timely documentation in alignment with site procedures and regulatory expectations.
- Support project timelines and provide regular status updates to project leads or site CQV managers.
- Contribute to the development of SOPs related to qualification, equipment maintenance, and validation lifecycle management.

**Requirements**:

- Bachelor’s degree in Engineering, Life Sciences, or related field (e.g., Chemical Engineering, Biotechnology, Pharmaceutical Sciences)
- 3-5 years of relevant CQV experience in a GMP QC or laboratory environment, preferably within the biopharmaceutical industry
- Strong knowledge of CSV (Computer System Validation), data integrity requirements, and analytical instrumentation
- Excellent documentation, communication, and organizational skills
- Ability to work cross-functionally with QC, Engineering, QA, and external vendorsIt is a 1 yr contract and may be extend.

**_Why PharmEng Technology?
- **

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

**_EEOC Statement
- **

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

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