Skills: Manufacturing Engineering, QA / QC / Inspection
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Job Title: Validation Specialist
Contract Duration: 7 months
Location: Woodlands, Singapore
Salary: Market Competitive Hourly Rate
My client is a world renowned manufacturer within the Biotechnology space. They are currently working on a new, fast - paced biotech project and are seeking a Validation Specialist to assist.
- Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation in accordance with Takeda's internal procedures and industry standards.
- The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
- Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Experience in coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
- Experience in leading daily validation meetings with cross functional in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
- Knowledgeable on Data Integrity topics
- Regular progress report of project deliverables to supervisor/project lead
- Any other duties as assigned by supervisor/designated person.
- Proficient in technical write up of validation lifecycle documentation (e.g. validation project plan, validation protocols, validation reports, validation discrepancies)
- Flexible working hours based on project schedule/timeline
- Knowledge in validation aspect under GMP environment
- Proficient in application of risk assessment such as FMEA
- Excellent communication skills (verbal and writing) and analytical thinking.
If you know anyone who may be suited for this role, and is available to carry out a 7 month contract, please refer them to me. We offer referral fees on successful placements.
All the best & good luck!
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