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Roche

Validation Engineer Trainee - Attach & Train program

Roche
BiopharmaSingaporeFull-time2 days ago
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About the role

AI summarised

Validation Engineer Trainee position at Roche's biotech contract manufacturing facility in Singapore. The role supports validation lifecycle for manufacturing processes and equipment, ensuring compliance with GMP and regulatory requirements. Ideal for recent graduates with a degree in Life Sciences or Engineering and 0-3 years of experience.

BiopharmaFull-timeGeneral

Key Responsibilities

  • Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.
  • Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.
  • Provide guidance and direction on all validation activities at the Singapore site.
  • Ensure that all validation activities with respect to process, cleaning, facilities/equipment and computerized system stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
  • Participate actively in investigations or troubleshooting discrepancies/ deviation encountered during commissioning and qualification.
  • Generate training materials and to conduct workshops on general validation activities.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Participate in site Validation Maintenance Program.
  • Prepare and review Turnover / Vendor Packages.
  • Support Change Implementation on site.
  • Support Validation / QA Audits as required, including Material Traceability Audits.
  • Participate in external regulatory inspections as SME.

Requirements

  • Degree in Life Sciences or Engineering discipline or equivalent
  • 0-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
  • Related working experience in a biotech or pharmaceutical operation environment is preferred
  • Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
  • Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
  • Good oral and written communication skills
  • Meticulous and Systematic
  • Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule
  • Must be highly motivated, able to work independently as well as a Team player, with strong focus on Safety, Quality and timeline.