Job Title: Validation Engineer
Hiring Manager: Senior Manager Validation (Modulus Singapore)
Location: Tuas, Singapore

About the job

Mission

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. The facilities are highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.

This role is responsible for implementing and maintaining qualification and validation strategies, plans, protocols, and reports, in collaboration with internal and external stakeholders.

The role will report to the Senior Manager, Validation. In this role, the (Senior) Validation Engineer, will play a key role in ensuring all equipment, facilities, cleaning and disinfection are properly qualified, validated and maintained in their Q&V status.

Key accountabilities

• Execute qualification and validation plans, protocols, and reports, in collaboration with internal and external stakeholders.
• Ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards.
• Ensure that assigned equipment and facilities are properly qualified; equipment cleaning and sterilization processes (e.g. autoclave, VHP, SIP) as well as surface disinfection (chemical and UV) are properly validated
• Ensure the proper documentation, review, and approval of qualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports
• Conduct periodic reviews of validated systems and perform re-validation as necessary.
• Identify and drive continuous improvement initiatives and projects to enhance the qualification and validation efficiency and effectiveness fostering a culture of continuous improvement
• Subject matter expert (SME) for validation topics.
• Lead and participate in equipment investigations to identify root causes and effectively communicate to the stakeholders on the plans and mitigating actions.
• Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
• Actively seek opportunities for continuous improvement through use of new technologies and best industry practices as well as establishing framework for validation.

Scope and dimensions

• Breadth of responsibility (global and site):
• Scope is local, focus primarily on activities in Sanofi Tuas site, with some transversal engagement with product donor site or Global experts.
• Impact on defining, designing, and implementing the framework and best practices for validation lifecycle management.
• Various interactions specifically with Manufacturing Operations, Quality, MSAT teams and beyond with all project functions involved in the process approach definition (HSE, Quality, Digital, Supply chain) as well as with external contractors and suppliers.

About you

Skills and knowledge expected

• Good knowledge of commissioning and qualification activities including use of Kneat
• Good shopfloor and operational knowledge of GMP, Validation and Biopharmaceutical processes including use of single-use technologies
• Good communication skills and a team player
• Proven ability to work as part of an integrated, networked team, and collaborate across functional, organizational, and location boundaries and be people-first values driven
• Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions
• Engaging, dynamic
• Adaptable, relationship focused
• Self-organized
• Proactive, Result-oriented

Education and experience

• Experiences in Validation and biotech manufacturing or process engineering
• Demonstrated experience in driving innovation and change to improve efficiencies
• Bachelor’s degree in Engineering, with at least 4 years of related experience
• Fluent in English (writing and speaking)