Job Description

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.Scope & Responsibilities:

• Propose changes to the batch record to the global design team. These changes will enhance alignment with site operation procedures and the manufacturing process.
• Attend routine meetings on a weekly basis to provide updates as required.
• Responsible for the development, configuration, and testing of Master Batch Records (MBRs) Parameter Value Lists (PVLs) from initial to final design.
• Collaborate with cross-functional teams and drive change management related to GMBR implementation (Upstream, Downstream, and Supporting electronic records).
• Propose changes to site operation procedures to facilitate seamless site implementation of standardized GMBR to the company.
• Manage and track change requests for standardized GMBR from other functions, including but not limited to Manufacturing (MFG), Process Development (PD), and Quality Assurance (QA).
• Work with the necessary cross-functional teams to execute dry/wet testing with the GMBR, document observations, and rectify design issues.
• Perform MBR development design reviews, including liaising with Operations, Process Development, and Quality functions.
• Oversee applicable equipment integration design, configuration, and testing to enable MBR interaction with shop floor equipment, including OSI PI and Recipe Managers like DeltaV.
• Handle other responsibilities as deemed necessary.

Qualifications:

• At least 3 years of MES experience in Process Engineering.
• Those with Upstream/ Downstream experience are preferred.ort to manage Amgen\'s enquirie during Amgen\'s normal working hours and

after hours (if required).
\xe2\x9a\xab Provider will place experienced and qualified personnel with the appropriate level of training
and experience at Amgen site for durations based on Amgen needs. The change of resources
shall be approved by Amgen.
\xe2\x9a\xab Periodic review on service level performance based on agreed KPI if required. Frequency to
be aligned between Provider and Amgen.
\xe2\x9a\xab Personnel is encouraged support and make recommendation to Amgen for continuous
improvement including but not limited to cost reduction, technical support etc.

No deviation