Assoc. Specialist, Engineering (CCP for Biomedical Manufacturing Industry)
Summary
Process Engineer in a pharmaceutical manufacturing plant, improving safety, quality, and efficiency in API production while ensuring regulatory compliance and supporting continuous improvement projects.
THE OPPORTUNITY:
- Join a Global Innovative Pharmaceutical Company
- Great opportunity for Personal and Professional development
Our engineers support manufacturing operations remain operational, continuously improve and innovate. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement to ensure supply of highest quality of raw materials, intermediates, and finished products and support our global manufacturing network. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Chemical, Automation, Capital Projects, Maintenance, Safety, Environmental, Technical Services and Utilities.
WHAT YOU WILL DO
As a Process Engineer you will provide process engineering support for manufacturing operations to support continuous improvement to drive safety, quality, process efficiency and compliance in cGMP manufacturing environment. Expected to support various initiatives leveraging quality, safety and project management platforms, engineering standards, codes, technology and supports department business goals and objectives.
Other main responsibilities include:
· 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 PerformanceManagement and Employee Development Plan (EDP).
· Participates in process hazards analyses(PHA) and applicable Process Safety Management (PSM) activities related tone w/inline products. Supports EHS audits and Safety incident investigations.
· Support energy initiatives & cost reduction projects
· Any other duties as assigned by the Supervisor.
WHAT YOU MUST HAVE
· 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.
· Project management skills to scope, plan, cost and implement actions in-collaboration with multi-functional teams.
WHAT YOU CAN EXPECT
· Limitless opportunities across various areas in Pharmaceutical Manufacturing.
· A state-of-the-art facility that delivers solution to its customers world-wide
· Highly engaging team that aims to innovate the future
· Chance to work above site functions, project management exposure and be part of continuous project improvement plan.