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 Verification (CQV) Engineer with solid experience in pharmaceutical engineering, equipment qualification and pharmaceutical solutions in the Life Science industries for a role in Singapore.
Objectives of this Role:
As a CQV Engineer, you will be responsible for the executing of Commissioning and Qualification tasks within a variety of small to large scale projects. You will manage CQV projects individually as well as work within a multi-disciplinary team where you can have great influence and responsibilities. This role requires a full-time commitment with on-site presence at our client's office in Singapore.
You will ensure that the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance/standards and provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities and site unplanned events.
Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. All work undertaken needs to be in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). With your extended experience in CQV engineering and preferably project management you would be considered a great and valuable asset to our company.
The CQV Engineer will develop CQV planning documents to manage CQV projects and generate and execute CQV protocols using Good Documentation Practices (GDPs). He will investigate and resolve protocol exceptions or discrepancies and develop technical reports and CQV summary reports. He also reads and verifies facility and equipment drawings (e.g., P&IDs, ), develops Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation and performs risk assessments and impact assessments.
Skills and Qualifications:
• Bachelor’s or Master’s degree in Mechanical Engineering, Chemical Engineering, Science or related technical field;
• Solid engineering (5-7 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP is desirable; junior with a minimum of 2 years is welcome to apply.
• Proven experience in projects coordination, engineering and CQV for bio process equipment and process support systems.
• Willing to take initiative, being proactive, taking responsibility and ownership;
• Strong communicative and interpersonal skillset;
• Customer-oriented, passionate and able to effectively switch between different assignments;
• Ambitious and enthusiastic relation builder with a quality-driven mindset;
• Proficient in English, both in speaking and in writing.
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.
