Validation Engineer

About the Role Maintain the site’s Right to Operate and enable manufacturing excellence by providing validation support to the production organization. Own and execute the validation lifecycle from Plan to Retire for manufacturing processes and equipment, ensuring compliance with PQS and HA requirements. What You'll Do

• Support day-to-day operation of approved Validation SOPs / Plans / 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 systems 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.
• Contribute, whenever possible, to raising the site awareness on the importance of validation at the Singapore site and within the industry.
• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately. What We're Looking For
• Experience in validation activities at a GMP biotech contract manufacturing facility, with multi-platform and multi-product responsibility.
• Ability to develop Validation SOPs, templates, guidelines, Validation Protocols and Reports; manage site discrepancies and deviation investigations/closures.
• Strong capability to provide guidance and direction on validation activities at the site level and to act as a technical SME.
• Knowledge of PQS and HA requirements and ability to ensure compliance.
• Experience with audits, vendor turnover packages, change implementation, and regulatory inspections.
• Demonstrated training and workshop facilitation skills; ability to train others and generate materials.
• Commitment to safety, health, environmental, and site security requirements. Nice to Have
• Experience with validation of computerized systems and integration into QA programs.
• Familiarity with Material Traceability Audits and cross-functional collaboration on validation topics.
• Experience in Validation Maintenance Programs and Change Management processes. Compensation & Benefits
• Salary and benefits are not disclosed in the posting.