Location: Singapore based
HGP Asia - Management Consultancy is looking for a Validation Engineer Consultant to work on the projects for Pharma & Biotech companies in Singapore.
Working for HGP Asia gives you an opportunity to work in a professional consultancy, take on responsibility and help shape the company. This role may be important on your career path as it will provide you with a wide knowledge and experience that is much appreciated on the labour market nowadays, hence you will stand out of the competitors in the future.
It is a great chance for you to show your skills and possibilities in the leading pharma companies across Asia, gain experience & constantly develop in Life Science environment, make contacts & share knowledge with colleagues in the industry.
As a Validation Engineer, you will be responsible for the support all aspects of quality, validation and qualification activities including process equipment, facilities and system for a commercial scale API process transfer.
- Develop risk assessment, system impact assessments, validation plans/strategies, protocols and reports that support the qualification & validation of process and utility systems.
- Develop moderate to highly complex protocols for validation projects
- Review, analyze, interpret & summarize system and process performance data of executed activities for report and presentation to management.
- Investigate deviations, write investigation reports & create summary reports.
Professional Skills and Experience:
- 2+ years (Analyst) or 4+ years (Consultant) experience in Validation, manufacturing, engineering or quality operations
- Advanced knowledge in one of GMP validation discipline such as: CIP/SIP/process/utility/computer system/serialization/equipment or automation
- Good understanding of risk-based approach as FMEA, PHA etc. per ICH Q9
- Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, I7OC protocols etc.)
- English (Professional working proficiency)
Who we are:
Halfmann Goetsch Partner AG are a business consultancy specializing in Life Sciences. We are global partners for Digital Transformation and Compliance in the pharmaceutical industry. Our consultancy services include Information Risk Management, Data Privacy (GDPR), Data Integrity, Computer System Validation (CSV), MES, GMP, Serialization and Audit Readiness.
HGP is based in Switzerland, with regional headquarters in Germany (Frankfurt), Singapore and Indonesia as well as a recruitment branch, HGP Life Path. Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out global projects with the necessary expertise and presence.
Our clients are global corporations, small and medium enterprises, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and software providers for the pharmaceutical industry.
If you are interested, please contact Magdalena Chorazy, Recruitment Consultant in HGP Asia. You can call me on +4969348 793259 or send your CV to firstname.lastname@example.org
Keywords: validation, CSV, MES, manufacturing, Malaysia, Philippines, India, Singapore, URS, FRS, GMP, Engineering, quality operations, CIP, SIP, English, GxP