1. Microbiologist 2. CSV Validation Engineer (US Pharma/ Medical MNC)
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Conduct environmental monitoring within the manufacturing setting
• Perform personnel monitoring for cleanroom gowning and operational investigations
• Conduct acceptability testing for media, biological indicators, and reagents
• Perform testing on in-process and final pharmaceutical product samples for release including pH, sterility, bioburden, and endotoxin testing
• Perform bacterial and mold identifications for unknown cultures and process biological indicators
• Accurately read and record results for all testing and testing activities
• Prepare daily paperwork and prepare sample analysis reports
• Monitor and test purified water
• Compile or author protocols, reports, investigations, and data summaries
• Assist in development of test methods for raw materials, in-process, and finished goods samples
• Interact with internal departments for testing needs and coordinate tests performed at outside testing laboratories
• Min Bachelor Degree in Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent, preferably with 3-4 years of experience in cGMP Pharmaceutical, Biopharmaceutical or related manufacturing environment and/ or related laboratory experience.
• Min Diploma in Microbiology, Biological Sciences, Life Sciences, Biotechnology with minimal 8 years of related cGMP laboratory experience.
• Experience in conducting microbiological study, investigation and cost saving projects etc.
• Preferably experience in Lean or Six Sigma tools.
2. Validation Engineer
Job Summary –
- We are currently seeking a Validation Engineer to be responsible for conducting and delivering analytical and engineering studies to support cleaning validation, cleaning verification, thermal sterilization, thermal sanitization, and controlled temperature unit mapping for major GMP clinical and commercial equipment and facilities.
- Write, approve, execute, and close-out validation reports.
- Maintain GMP status of assigned suite areas and facilities.
- Responsible for project management to set and meet lead times for cleaning and sterile validation testing, elevate need for additional resources, and ensure equipment periodic revalidations stay on schedule.
- This position is on a client account within the pharmaceutical industry.
- Responsible for periodic revalidation of major process equipment in Clinical Pilot Plants and in Commercial Facilities.
- Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples.
- Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings.
- Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs).
- All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout.
- Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing.
- Planning, Performance, and Coordination of 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.
- Experience in Systems Validation background, preferably experience with DSC, SCADA and Delta-V or Siemens PCS systems in pharma manufacturing
- This is not an IT role, coding is not required
- Min 5 years experience working in a regulated environment
- Working knowledge of Standard Operating Procedures and Protocols/Reports
- Understanding of validation/qualification strategies
- Knowledge of applicable quality regulations and standards
- Quality or quality support experience in a regulated environment (GLP, cGMP, ISO)
- 3 years quality assurance or quality control experience in cGMP pharmaceutical or drug development organization
- Working knowledge of facility equipment commissioning and qualification
- Working knowledge of process and cleaning validation
- Working knowledge of System Validation
- Quality assurance or quality control experience in a cGMP pharmaceutical setting
- Education: B.S. in an Engineering discipline, or Life Science degree
- Required: 3-5 years quality or quality support experience in a cGMP pharmaceutical setting
- Desired: 4-7 years facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting
- Sound working knowledge of processing equipment used to manufacture APIs
- Knowledge of clean room standards
- Professional Skills, Qualifications and Experience:
- 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.
- 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
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Microbiologist or Validation Engineer - Leon)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd