Manufacturing Biotechnologist

4 days ago


Singapur, Singapore HILLEMAN LABORATORIES SINGAPORE PTE. LTD. Full time
Job Title: Manufacturing Biotechnologist

We are seeking a highly skilled Manufacturing Biotechnologist to join our team at Hilleman Laboratories Singapore Pte. Ltd. As a key member of our manufacturing team, you will be responsible for ensuring the safe and compliant execution of manufacturing activities.

Key Responsibilities:
  • Execute manufacturing activities in a safe and compliant manner, adhering to cGMP practices and regulations.
  • Ensure accurate and complete data recording in Manufacturing Batch Records (MBRs) and forms, following ALCOA principles.
  • Participate in tech transfer activities, providing input on operation and equipment setup for new products and processes.
  • Draft, author, and review documents, including facility fit assessments, user requirements, raw material identification, batch records, SOPs, and process recipes.
  • Perform front-line troubleshooting of Fill Finish equipment and contribute to Total Productive Maintenance (TPM) activities.
  • Coordinate with relevant departments and stakeholders to ensure project milestones are met and progress is tracked.
  • Lead root cause analysis for operational-related deviations and investigations, utilizing established problem-solving tools.
  • Complete required training on time to ensure operations are conducted in a safe manner.
  • Support process/equipment qualification/validation activities and studies.
  • Represent the department as a Subject Matter Expert (SME) during regulatory audits.
  • Perform cleaning of equipment and cleanrooms as necessary and maintain basic 5S housekeeping standards.
Requirements:
  • Bachelor's degree in a relevant engineering or scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with 2-6 years of relevant industry experience.
  • Plant start-up or commissioning experience in biologics and/or vaccines, with knowledge of cGMP practices applicable to Fill Finish processes.
  • Thorough understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
  • Well-organized, detail-oriented, and able to effectively prioritize tasks with agility, with excellent communication and interpersonal skills.
  • Team player with good working ethics, initiative, diplomacy, positive influencing abilities, and drive.
  • Good oral communication and exemplary writing skills, with experience in problem-solving and statistical tools an advantage.

Tell us about your skills:

Recipes
Troubleshooting
Housekeeping
5S
GMP
Root Cause Analysis
Reliability
Manufacturing Operations
Finish
Audits
Diplomacy
Total Productive Maintenance
Manufacturing
Writing Skills
Commissioning



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