Job Description :
The key responsibilities of the Validation Specialist are as follows:
• Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with 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,
• Experienced 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.
• Can lead investigation revolving around discrepancies identified during qualification activities.
• 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)
• Regular progress report of project deliverables to supervisor/project lead
• Any other duties as assigned by supervisor/designated person.
Education and Experience Requirements
• Proficient in use of MS Office
• 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
• Experience in quality management systems is preferred
• 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.
• Able to execute activities in cGMP environment, including cleanrooms or technical areas.
Professional Skills, Qualifications and Experience:
• Education: B.S. in an Engineering discipline, or Life Science degree
• Min 5 years experience working in a regulated environment
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.
• Ability to utilize GDP during document creation and review.
• Working knowledge of current regulatory guidelines and standards.
• Quality or quality support experience in a regulated environment (GLP, cGMP, ISO)
• Knowledge of applicable quality regulations and standards
• Understanding of validation/qualification strategies
• Working knowledge of process and cleaning validation
• Ability to apply and incorporate pharmaceutical standards, rules and guidances. (e.g. FDA, EU, ISO, ICH, ISPE, etc.)
• Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
• Flexible and accountable.
• Detailed oriented work standards.
• Office Hours 5 Days
Interested candidates please send a copy of your resume to [HIDDEN TEXT]
Email Subject: Validation Engineer – Leon
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Simple body text this will replace with orginal content