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Cleaning Validation Engineer

2 weeks ago

Singapore PSC BIOTECH PTE. LTD. Full time

**Responsibilities**:

- Working in a biotech/pharmaceutical environment as a consultant / contractor for various clients of PSC
- Working closely with client's employees on various projects and various GMP facilities to help client with validation issues
- Commuting to PSC clients' manufacturing for validation projects
- Protocol development (IQ, OQ, PQ) / protocol review for process equipment qualification and cleaning validation activities
- Design and develop cleaning procedures for new products and manufacturing equipment
- Supports the periodic review of cleaning validation studies.
- Work independently and as a part of a team to achieve completion of process equipment qualification and cleaning validation tasks
- Perform process qualifications and cleaning validation, including report writing where required
- Support cleaning validation studies and activities
- Manage deviations, change controls and CAPAs

**Requirements**:

- Bachelor of Science / Bachelor of Engineering or related scientific degree
- At least 3 years of validation experience in a pharmaceutical environment, with prior process equipment qualification / cleaning validation experience. Incumbent with more years of experience may be considered for a senior role
- Prior work in maintaining GMP biotechnology and/or sterile process equipment is a plus
- Strong analytical mind with good problem solving and writing skills
- Highly motivated and independent
- Possess strong interpersonal and communication skills, with ability to work within cross-functional teams
- Organized and result-oriented
- Be able to function successfully in high pressure fast moving multi-discipline / Multi-cultural team project environments
- **Must be comfortable with Contract basis role