Provide Process Engineering Support for API manufacturing plants in support of business continuity to meet Safety, Quality, environmental, continuous improvement, regulatory and compliance objectives.
Support Deviation management related to the equipment, systems in response to deviations/ adverse events to investigate and identify point of occurrence, root cause and corrective/ preventative actions.
Support global change management under various execution platforms to endure the equipment, facility, and system changes are executed complying to design standards, safety standards, and quality procedures.
Support minor capex projects through evaluation of scope, feasibility, design, project proposals, sourcing plan, installation, commissioning & qualification with adherence to site change control procedures within the allotted timeline, budget, design requirements, and established quality standards.
Demonstrates good project management skills (e.g. define core team and activities, project scheduling, stakeholder management, and issues escalation etc), and demonstrates the ability to manage/ influence the project team.
Execute portfolio projects to introduce new technology, engineering standards recommendations, and new code and practices to support process & energy efficiencies, process safety, and quality compliance.
Provides technical support during quality and safety external audits / internal inspections in providing technical representation and/or assessments in response to the auditing firms and other regulatory agencies.
Perform gap assessment & periodic review of current engineering & business procedures, update SOPs and train the impacted personnel.
Demonstrates leadership behaviors and leads personal career development with manager assistance through Performance Management and Employee Development Plan (EDP).
Participates in process hazard analyses (PHA) and applicable Process Safety Management (PSM) activities related to new/inline products. Supports EHS audits and Safety incident investigations.
Support energy initiatives & cost-reduction projects
Any other duties as assigned by the Supervisor.
Requirements & Skills:
Bachelor’s degree in chemical engineering or biochemical engineering.
Knowledge of GMP systems, equipment qualification, and commissioning
Possess unit operations, equipment knowledge and trouble shooting skills.
Perform Process hazard analysis, FMEA and Risk assessments.
Application of engineering fundamentals to carry out feasibility studies and develop implementation plans.
Understanding of Project management skills to scope, plan, cost and implement actions in-collaboration with multi-functional teams.
