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 to 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.
Requirements:
Having working knowledge on OT systems (i.e. MES system (Syncade), Delta-V, building automation system, PI Server etc) is advantageous.
Experience working in pharma / GMP environment is preferred.
Proven track record and strong experience in IT Infrastructure and hands-n operationally - supporting IT computer network infrastructure and software project management
At least 2-3 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in process validation is preferred. Degree in Science/Engineering discipline with proficiency in English is required.
Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility.
Good oral and written communication skills
Meticulous and Systematic
Team player, with strong focus on safety, quality, and timeline