Project Engineer

Project Engineer – Consultant position Job Description: • Contribute to Life Science projects for Antaes Asia clients • Develop and execute C&Q documentation including commissioning protocols, SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices. • Support end-to-end C&Q lifecycle for process, utility, and support systems — e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities. • Manage execution of commissioning and qualification activities in alignment with project schedules, safety standards, and GMP compliance. • Support automation qualification (DeltaV, PLC, SCADA) and ensure integration with process control systems. • Review vendor documentation and coordinate SAT with suppliers and engineering teams. • Troubleshoot and resolve technical issues encountered during C&Q execution. • Ensure all C&Q deliverables meet internal Quality and Validation standards, and align with site Validation Master Plan (VMP). • Support handover of qualified systems to Manufacturing and Maintenance teams, including training and documentation. • Collaborate closely with cross-functional teams including Engineering, QA Validation, Manufacturing, and Automation. • Contribute to the promotion of Antaes services on top of assistance provided to clients Job Requirements: • Bachelor’s Degree in Chemical, Mechanical, Biomedical, or related Engineering field. • 3–7 years of CQV experience in the pharmaceutical industry • Strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and FDA/EMA validation expectations. • Experience in process equipment qualification (bioreactors, chromatography, UF/DF, CIP/SIP), clean utilities, and automation integration. • Familiar with risk-based CQV approach and change control processes. • Proficiency with documentation management systems (e.g., Veeva) • Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills • Excellent communication skills, both written and verbal, in English -------------------------------------- Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 10 consulting companies in Switzerland. We have over 300 experienced engineers who share our passion. Present in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas: • Organizational and transformation consulting • Industrial engineering • Information systems management By joining our teams, you will discover: • A dynamic team with a start-up mindset • Personalized support and career development follow-up • Opportunities to expand your network through exciting challenges • Events: team buildings, meet-ups, workshops, Summer Event • A company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025 You too can be part of the Antaes adventure :) We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted. Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.