Responsibilities:
- Support process validation and characterization studies.
- Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely manner or in accordance with project timelines.
- Manage the execution of process validation and characterization studies and associated deviation investigations.
- Collaborate with cross-functional teams to arrange, plan, and ensure smooth running and execution of the process validation activities.
- Support relevant process and technical change management and change implementation activities.
- Support any other tasks as assigned by the supervisor.
About You:
- Bachelor Degree in Engineering, Biotechnology, Science, Industrial Instrumentation and Process controls or related courses
- At least 5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in process validation is preferred.
- Knowledge and ensure compliance with cGMP and safety regulations;
- Liaise with stakeholders to ensure proper implementation
- Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams
