Senior Engineer, Validation (Modulus)

About the Job

The Sanofi Modulus team in Singapore is seeking to expand the team and has an open position as Senior Engineer, Validation. This role is responsible for executing qualification and validation 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 Engineer, Validation will play a key role in ensuring that assigned equipment, facilities, cleaning and/or disinfection are properly qualified, validated and maintained in their Q&V status.

The Senior Engineer (Validation) is accountable to:

• 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 the proper documentation, review, and approval of qualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports

• Ensure that assigned equipment and facilities are properly qualified and validated

• Ensure that equipment cleaning is properly validated

• Maintain the validation of sterilization cycles (e.g. autoclave, VHP, SIP) and surface disinfection (chemical and UV)

• Execution of qualification and validation studies

• 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

About You

• Bachelor’s Degree in a related Engineering or Science discipline.

• Ideally more than 5 years of relevant working experience in the cGMP biopharmaceutical facility.

• Previous hands-on qualification/validation experience with equipment, facilities, cleaning and disinfection would be an advantage.

• Experience in change management, stakeholder management, process innovation and optimization

• Able to work in fast paced and dynamic conditions with tight timelines.

• Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions.

• Effective communication skills necessary to interact with internal stakeholders (includes strong presentation skills).

• Good technical writing skills.