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Primary role:
. Design Mechanical/Electrical/Instrumentation(M/E/I) system/equipment/piping and project implementation through installation, commissioning, validation, documentation, maintenance and operation troubleshooting in accordance with plant specification, cGMP, EHS and regulatory requirements.
. Carry out cost estimation, planned scheduled using MS Project software, project cost control and project report.
. Carry out bid preparation, site show, evaluate, recommendation and safety briefing for M/E/I equipment vendor and contractor for the project.
. Work with cross function Project team to support other project activities meeting cost, schedule and in compliance with cGMP, EHS and regulatory requirements.
. Carry out project safety reviews such as Risk Assessment, Hazop, PSSR etc.
. He/she should be the Front-Line Leaders (FLL) with strong understanding of GMP and good data management practices. He/she should ensure an active daily presence in GMP work area to observe work activities and practices within the role responsibilities.
. He/she is accountable for Project expenses, Project schedule, Project Safety, Project team performance and Good Data Management and Data Integrity
Primary responsibilities:
. Evaluate equipment and system (including piping) integrity by conducting feasibility study and applying principles of mechanics, thermodynamics, hydraulics, heat transfer and materials.
. Knowledge in equipment reliability on methods through fabrication, assembly, installation processes, testing and validation methods.
. Develop testing and validation procedures (with Quality/Validation) by studying test requirements and operating methods.
. Prepare bidding document/drawings, carry outbid evaluation and recommendation.
. Provide engineering information support by coordinating OEM training, developing OJT training materials (with respective maintenance team).
. Liaise with Professional Engineers, consultants and government bodies on any planning and submission requirements for project and modification of change (MOC).
. Complete assigned projects and modification of change (MOC) without compromise on safety, schedule, specification, quality and within budget.
. Lead/drive/support the team to focus on Safety and GMP Compliance as operational priorities (including metrics), know the process and procedures, including the principles and practices of ALCOA.
. Develop effective monitor action for team. Ensure daily presence in GMP work area to observe work activity and practices within their role responsibilities. Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
. Lead/drive/support the team for real time escalations of any concerns or needs. Observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP processor activity.
Responsible for the site KPI's which include:
Organizational Relationship
Financial & Resource Management
Qualification
Skills and Experience
Job ID: 151523485