Job Scope

• Contribute to Life Science projects for Antaes Asia clients
• Develop and maintain detailed CQV schedules using project planning tools (e.g., MS Project), aligned with overall project timelines.
• Collaborate with engineering, validation, QA, QC, and operations teams to plan and sequence commissioning, validation and qualification activities.
• Monitor progress, identify schedule risks, and implement mitigation strategies to ensure timely delivery of CQV milestones.
• Support the development and execution of CQV strategies, including URS, DQ, IQ, OQ, and PQ documentation and activities.
• Ensure CQV activities comply with GMP, FDA, EMA, and other applicable regulatory standards.
• Facilitate planning meetings, progress reviews, and reporting to project stakeholders.
• Coordinate resource planning and availability for CQV tasks, including vendor and contractor support.
• Maintain accurate documentation and change control records related to CQV scope.
• Support audits and inspections by providing schedule-related documentation and insights.
• Ad-hoc duties as assigned by Supervisor.
• Contribute to the promotion of Antaes services on top of assistance provided to client.

Job Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum 3 years of experience in project planning within a GMP-regulated pharmaceutical environment.
• Strong understanding of CQV processes and lifecycle documentation (URS, DQ, IQ, OQ, PQ).
• Proficiency in project scheduling software (Primavera P6, MS Project, etc.).
• Familiarity with ISPE Baseline Guides and industry best practices for CQV.
• Excellent communication, organizational, and stakeholder management skills.

Good to have:

• PMP or equivalent project management certification.
• Experience with large-scale pharmaceutical capital projects (e.g., new facility builds, equipment upgrades).
• Knowledge of computerized systems validation (CSV) and data integrity principles.
• Experience with digital validation platforms (e.g. KNEAT) or eQMS systems.