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.
Overview:
The Manufacturing Associate (MES) will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have one to two years of experience in a pharmaceutical or biotech industry and will have demonstrated competency to deliver MBR designs in time with project timelines.
The ideal candidate will have:
Technical understanding in MES systems.
Experience of working in bulk manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.
The ability to adapt quickly to the demands of commercial manufacturing operations.
Job Scope:
MES Technical Expertise
Responsible for the development, configuration and testing of Master Batch Records (MBRs) Parameter Value list (PVLs) from initial to final design.
Responsible for performing MBR development design reviews including liaising with Operations, Process Development and Quality functions.
Responsible for drafting, executing, and reviewing Application Lifecycle Management (ALM) test scripts and test sets for testing MBR design.
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - DeltaV
Other Responsibilities as deemed necessary.
Compliance/Quality
Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture.
Knowledge and Problem Solving
Handles diverse scope of issues that require evaluation of a variety of factors.
Implement, assign, lead or participate in projects.
Applies analytical skills to evaluate and interpret situations / problems using multiple sources of information.
Anticipates and prevents potential problems.
Basic Qualifications & Relevant Experience preferred:
Master’s degree in Engineering or Science
OR
Bachelor’s degree in Engineering or Science and 1year of Manufacturing experience
OR
Associate’s degree in Engineering or Science and 2 years of Manufacturing experience
Working knowledge of manufacturing in pharmaceutical/biotech industries
Knowledge of regulation requirements (GMP & EH&S)