About this role
Key Responsibilities • Engage with Business SMEs and Key Users to gather, analyze, and document manufacturing requirements • Translate business needs into functional and technical MES solutions • Collaborate with MES engineers to design, configure, and test system functionalities • Design and develop Process Instructions (PIs) aligned with site-specific manufacturing processes • Identify commonalities across sites and develop global PIs/templates for reuse and standardization • Perform validation activities for MES solutions in compliance with regulatory standards (e.g., GxP) • Create and maintain project documentation, including: User Requirement Specifications (URS) Functional Requirement Specifications (FRS) Design Specifications (DS) Test Scripts (IQ/OQ/PQ support) • Lead a team of consultants/engineers, assign tasks, and ensure timely delivery • Provide regular status updates to internal management and customer stakeholders • Support system deployment, user training, and post-go-live activities • Any other adhoc duties as assigned. Required Qualifications • Bachelor’s degree in Engineering, Computer Science, or related field • 4–10+ years of experience in MES, preferably in pharma or life sciences • Hands-on experience with Siemens Opcenter Execution Pharma (Simatic IT eBR) • Strong understanding of electronic batch records (eBR) and manufacturing workflows • Experience with validation processes in regulated environments (GxP, CSV) • Proven experience in documentation (URS, FRS, DS, test protocols) • Leadership experience or ability to manage small teams Interested applicants, please Email , and look for Jensen Fang Lifa Recruit Express Pte Ltd EA License No. 99C4599 EA Personnel Registration Number: R2197080 We regret that only shortlisted candidates will be contacted.
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