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