CSV Consultant

Key Responsibilities:

• Deliver CSV consulting projects to support implementation of computerized systems (e.g., DeltaV, Siemens PCS7, Rockwell PLCs) in the Life Sciences clients with compliance of GxP and other relevant regulatory standards.
• Deliver CSV consulting projects to support OS upgrade (e.g., Windows 11 upgrade) for laboratory and manufacturing equipment.
• Draft, review and maintain CSV documentation such as URS, FDS, Risk Assessment, Audit Trail Assessments, ERES assessments, Data Security Assessment, Validation Plans, IOPQ Protocols, RTM and any other lifecycle management documents.
• Provide expert consultation to ensure compliance with current regulatory requirements (e.g., GAMP5, 21 CFR Part 11, Annex 11).
• Support system configuration and computerised system (CS) activities such as backup and restore, access management, etc.
• Manage stakeholders from cross-functional teams (IT, Quality, Engineering, Operations) to plan and implement validation activities.
• Collaborate with other stakeholders including IT/OT, automation and quality teams to deliver validation projects on schedule.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Possess 2-4 years of experience in Computer System Validation (CSV), Automation, or related quality and compliance roles within a regulated environment (pharmaceutical, medical device, etc.)
• Familiar with CSV lifecycle management and automation systems validation.
• Had experience in leading a project from planning through execution and reporting.
• Able to manage stakeholders and deliverables within project timelines.
• Must be able to work independently and deliver results under minimal supervision.
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
• Preferably with experience in change, incident and problem management.

Why Join Orka:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.