- Location: Singapore
- Employment: Permanent
- Sector: Life Sciences / Pharmaceutical Engineering
Job Details
We are partnering with an international engineering design and consultancy company supporting the Life Sciences, Pharmaceutical and Biopharmaceutical sectors to identify an experienced CQV Engineer for their Singapore team.
The position will be particularly suited to candidates with strong experience in the commissioning, qualification and validation of analytical laboratory instruments within GMP-regulated pharmaceutical or biopharmaceutical environments. The successful candidate will be involved across the validation lifecycle, from early-stage requirements and risk assessments through to commissioning, qualification execution and final validation reporting.
A significant part of the role will involve qualification of analytical systems such as HPLC, UPLC, GC, Mass Spectrometers, UV-Vis, FTIR, Dissolution Testers, Particle Size Analyzers and Osmometers. You will prepare and execute documentation including URS, Functional Specifications, System Impact Assessments, FMEA/Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and qualification reports.
The role will also provide exposure to the qualification of biopharmaceutical process and manufacturing equipment, including bioreactors, fermenters, chromatography systems such as ÄKTA, TFF systems, automated cell counters, incubators, deep freezers and other GMP equipment. You will work closely with engineering teams, quality functions, vendors and equipment suppliers to ensure qualification activities meet project and site quality requirements.
You will also support the investigation of validation or manufacturing deviations, review system performance data, assist with Root Cause Analysis and CAPA, and ensure all activities are performed in accordance with cGMP, Good Engineering Practice and applicable pharmaceutical regulatory standards.
Job Requirements
- Degree or Diploma in Biotechnology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or a related discipline.
- Approximately 5–15 years of experience within CQV, validation, pharmaceutical engineering, quality or GMP manufacturing.
- Strong hands-on experience in analytical instrument qualification.
- Good knowledge of the validation lifecycle including URS, FRS/FS, FAT, SAT, Commissioning, IQ, OQ and PQ.
- Exposure to risk-based, traditional or hybrid validation approaches.
- Experience working within pharmaceutical, biotechnology or biopharmaceutical manufacturing environments.
- Experience with bioprocess equipment qualification would be highly advantageous.
- Familiarity with systems such as Documentum, Maximo or TrackWise would be useful.
- Good experience handling deviations, investigations, RCA and CAPA.
- Strong technical documentation and stakeholder-management skills.
A valid passport and willingness to travel internationally when project requirements arise.
This is an excellent opportunity for a CQV professional looking to join an international Life Sciences engineering consultancy and gain broader exposure across analytical laboratories, biopharmaceutical equipment and complex GMP engineering projects.
Please be advised that due to the considerable number of applications we receive, we are only able to contact candidates who meet our client’s requirements.
We appreciate your understanding and wish you the best in your career endeavors.
Sathiyarajan Vinayagamani – SaVi
EA Personnel KAH Reg No: R1216080
EA License No: 23C1889
