Validation Engineer (Biopharmaceutical Manufacturing)

Location: Tuas, Singapore

Company

Pharmaceutical manufacturing and supply organization developing modular, digitalized and automated facilities for vaccines and Specialty Care Biologics products.

What you will do

• Execute qualification and validation plans, protocols, reports and related deliverables with internal and external stakeholders.
• Qualify equipment and facilities, including cleaning, sterilization and surface disinfection processes such as autoclave, VHP, SIP, chemical disinfection and UV disinfection.
• Ensure compliance with applicable regulatory requirements and company quality standards.
• Review and approve risk assessments, traceability matrices, test scripts, deviations and summary reports.
• Conduct periodic reviews, revalidation, change-control assessments and new-product-introduction assessments.
• Lead equipment investigations, identify root causes and drive continuous improvement in validation lifecycle management.

Requirements

• Bachelor’s degree in Engineering with at least 4 years of related experience.
• Experience in validation, biotech manufacturing or process engineering.
• Knowledge of commissioning and qualification activities, including use of Kneat.
• Operational knowledge of GMP, validation and biopharmaceutical processes, including single-use technologies.
• Strong analytical, diagnostic, communication and stakeholder-collaboration skills.
• Fluent English, written and spoken, is required.

Culture & Benefits

• Local focus on activities at the Tuas site with transversal engagement across product donor sites and global experts.
• Collaboration with Manufacturing Operations, Quality, MSAT, HSE, Digital, Supply Chain teams, contractors and suppliers.
• Opportunity to drive innovation, apply new technologies and establish validation best practices.
• People-first, inclusive and equal-opportunity working environment.