What you'll be doing?

• Project Delivery: Lead consulting projects implementing computerized systems in Life Sciences, ensuring compliance with GxP and regulatory standards.
• System Upgrades: Spearhead OS upgrade projects for laboratory and manufacturing equipment, enhancing operational efficiency.
• Documentation Management: Create and maintain comprehensive CSV documentation, including URS, FDS, and various assessments, ensuring regulatory adherence.
• Regulatory Expertise: Provide expert guidance on compliance with current regulatory requirements, keeping clients at the forefront of industry standards.
• System Support: Assist with critical system activities such as backup, restore, and access management, ensuring smooth operations.
• Stakeholder Management: Collaborate with cross-functional teams to plan and implement validation activities, fostering a culture of quality and compliance.
• Project Coordination: Work closely with IT/OT, automation, and quality teams to deliver validation projects on schedule, driving successful outcomes.
• Documentation Development: Contribute to the creation and revision of SOPs and related operational documents, maintaining best practices.

Who are they looking for?

• Educational Background: Hold a Bachelor's degree in Life Sciences, Engineering, or a related field, bringing a solid foundation to the role.
• Industry Experience: Minimum 2–4 years of hands-on experience in Computer System Validation (CSV) within the Pharmaceutical or Medical Device industry, including drafting, reviewing, and maintaining CSV documentation (e.g., URS, FDS, Risk Assessment, Audit Trail Assessment, ERES Assessment, Data Security Assessment, Validation Plans, IOPQ Protocols, RTM, and other lifecycle management documents), providing expert consultation on CSV activities, and supporting computerised system configuration, backup/restore, and access management.
• Technical Proficiency: Demonstrate familiarity with CSV lifecycle management and automation systems validation, applying your expertise to client projects. Strong working knowledge and experience with computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practices (e.g., ISPE GAMP5) in a Pharmaceutical or Medical Device environment, ensuring compliance in all validation and lifecycle management activities.
• Project Leadership: Show capability in leading projects from planning through execution and reporting, driving successful outcomes.
• Stakeholder Management: Excel in managing stakeholders and deliverables within project timelines, ensuring client satisfaction.
• Regulatory Knowledge: Understand computerised system regulatory requirements and industry best practices, staying current with evolving standards.

Jobs DB Singapore Pte Ltd | 24C2640
Low Jia Yi | R25127265
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