SGP
1 day ago
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. **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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