Position title: Metrology & Periodic Qualification Engineer
Reporting to: Head of Engineering & Maintenance
Location: Modulus, Tuas Singapore
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 technologies, to better address vaccine business challenges as well as Specialty Care Biologics products.
Manage periodic qualification (calibrations) of instruments for facilities, utilities and process equipment
Oversee maintenance of site electrical systems performed by site Facility Management partner; inclusive of high & Low voltage distribution panels, lighting, power, earthing, lightning and ELV system
System owner for paperless calibration; manage the setup of instrument calibration on paperless system
Troubleshoot the instruments and its related communication interface issues with Automation systems
Based on process requirements and usage information provided by users or system owners, devise device tolerance and calibration frequency.
SME for the site calibration and metrology program during the inspections and regulatory audits
Develop, revise and review SOPs, ensure all the instrument and related systems compliance are met
Ensure the training requirements are met for the Instrumentation (Metrology & Periodic Qualification) technicians
Manage instrumentation and electrical spares
Main Responsibilities-
SME on Electrical & Instrumentation (E&I) scope for assigned Tier3 (≤€5mil) projects
Represent business in engineering review for high & Low voltage distribution panels, lighting, power, earthing, lightning and ELV system
Review the instrument and its related specifications and ensure the user requirements are met
Support project execution, testing & commissioning, validation coordination for E&I scope
Review the construction drawings such as instrument loop drawings etc based on project specification
About You
Bachelor’s degree in Instrumentation and Controls / Electrical Engineering with 5-8 years in managing E&I
Industrial experience in the Biopharmaceuticals/ API industry
Experienced in commissioning smart sensors
Experience and knowledge on instrument communication protocols such as Profinet, Ethernet/IP, OPC UA, HART, Profibus PA/DP and conventional
Managing maintenance of site electrical systems
Interpretation of electrical, instrumentations & control diagrams
Strong technical writing, experience with drafting SOPs
Experience with deviation management will be added advantage.
Knowledge on OT-IT will be added advantage.
Good technical knowledge coupled with hands-on working experience in biopharmaceutical/ API engineering services.
Strong foundation in Current Good Manufacturing Practices (CGMPs)
Good knowledge in pharmaceutical regulatory market requirements and experience in participation of Audits. Eg;- FDA, EMA, HSA & etc.
Good knowledge in project procurement to handle vendor & subcontract management, RFQ, tender review, technical and commercial bid analysis report for the projects proposed.
Ability to lead contingent staffs, external resources, including vendors & contractors
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.
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