(Senior) C&Q Engineer at Sanofi

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

0.0

Posted On

27 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning & Qualification, IQ/OQ/PQ Protocols, GMP Compliance, FDA/EMA Regulations, ALCOA+ Data Integrity, Project Management, CAPA Development, HVAC Qualification, Cleanroom Qualification, Stakeholder Management, Risk Assessment, Contractor Oversight

Industry

Pharmaceutical Manufacturing

Description

About the job Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. As a (Senior) C&Q Engineer, you will be responsible for driving excellence across the following key areas: C&Q Strategy & Execution Develop and execute qualification protocols (IQ, OQ, PQ) for facilities, utilities, and equipment, inclusive of associated automation qualification Leverage and build upon the established C&Q strategy and framework from the Greenfield project, adapting and extending it for Tier 3 project requirements Apply global C&Q approaches to site-specific Tier 3 project needs while ensuring compliance with GMP, FDA, and other applicable regulatory requirements Project Delivery Drive end-to-end C&Q delivery for Tier 3 capital projects, encompassing design, execution, qualification, handover, and close-out phases Coordinate and oversee C&Q external contractors in executing project scope, ensuring quality standards, timeline adherence, and deliverable completion Work closely with Project Leads to integrate C&Q activities into overall project schedules, milestones, and critical path planning Provide C&Q technical input during project stage gate reviews and support site decision-making through recommendations and risk assessments Technical Expertise Serve as the key C&Q technical resource during quality-related discussions, audits, and inspections Lead investigations and develop CAPAs for qualification-related deviations or non-conformances Identify improvement opportunities for qualification processes and critical systems Implement process improvements to enhance efficiency, safety, and quality of C&Q activities Documentation & Compliance Manage C&Q digital platforms and electronic documentation management systems, ensuring optimal functionality, user access management, and continuous improvement Develop, review, and approve qualification documentation including protocols, reports, and summary reports in accordance with regulatory standards Ensure all C&Q documentation meets data integrity requirements (ALCOA+ principles) and complies with regulatory standards Collaboration & Communication Participate actively in Communities of Practice (COPs) and global expert networks to exchange best practices, drive innovation, and stay current with C&Q industry trends Contribute lessons learned, share technical insights, and co-develop solutions with global peers to advance C&Q excellence Support global C&Q initiatives and collaborate across regions to standardize approaches and improve efficiency Candidate Profile Qualifications Bachelor's degree or higher in Engineering (Chemical, Mechanical, Electrical, or related discipline) Minimum 6–10 years of experience in Commissioning & Qualification within the pharmaceutical, biotechnology, or related GMP-regulated industry Proven hands-on experience with IQ, OQ, PQ protocols for facilities, utilities, and equipment in a manufacturing environment Technical Competencies Strong working knowledge of GMP, FDA, EMA, and other relevant regulatory requirements Proficiency in data integrity principles (ALCOA+) and their application in C&Q documentation Experience with C&Q digital platforms and electronic documentation management systems Familiarity with HVAC, clean utilities, process equipment, and cleanroom qualification Project & Delivery Experience Demonstrated ability to independently manage C&Q scope for capital projects from design through to handover and close-out Track record of coordinating and overseeing external contractors to deliver on quality, schedule, and budget Experience integrating C&Q activities into broader project schedules and critical path planning Exposure to project stage gate processes and risk assessment methodologies Soft Skills & Leadership Potential Self-starter with the ability to hold the fort independently and take full ownership of C&Q deliverables with minimal supervision Strong problem-solving and investigation skills, with a proactive approach to identifying and resolving issues Excellent communication and stakeholder management skills, able to engage confidently with internal teams, contractors, and regulatory bodies Collaborative mindset with a willingness to contribute to global networks and communities of practice Demonstrated leadership qualities and a desire to grow into a people management role Preferred (Good to Have) Experience in Greenfield or large-scale capital project environments Prior involvement in site expansions, or Tier 3 (

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Responsibilities

Drive the end-to-end Commissioning and Qualification (C&Q) strategy and execution for Tier 3 capital projects, including facilities, utilities, and equipment. Manage external contractors and ensure all documentation complies with GMP and data integrity standards.