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Job Description
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
WHAT YOU WILL DO:
Provides engineering and troubleshooting support with the goal to increase operational efficiencies and minimize maintenance expenses.
Lead and Provides engineering support to the corrective and preventive maintenance for process equipment's such as filling machine, autoclaves, parts/tray washer, automatic visual inspection machine.
Assists with audits, conduct investigations (QualityNotifications), and identifies gaps related to process equipment's and implement necessary CAPA.
Tracks and completes all compliance related requirements.
Ensures installation, modification, fabrication, testing, servicing and repairs of equipment adhere to site change control procedures.
Ensures testing, commissioning, qualification (IQ, OQ) activities are executed accordingly and in compliance.
Develop, review and modifies new or existing site standards for maintenance and projects.
Ensures that projects deliverables are met, and all associated documentation is established.
Provides engineering support in the scoping, development, execution and documentation of upgrade projects.
Responsible for the management of single or multiple projects within the allotted timeline, budget, design requirements, and established quality standards
Retains ownership of previously delivered projects.
Identify, execute and make improvement on routine work activities.
Performs job assigned by Supervisor pertaining to equipment or system or documentation.
Establishes EHS objectives for projects and leads the implementation of systems.
Lead in all phases of new process control system projects, from planning to validation.
Development of technical procedures in a cross-functional setting with impact throughout the organization.
Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable
Supervise and oversee Third Party Contractors, where applicable
Standby for any emergency repair after office hours / weekends and public holidays
Should be independently able to handle deviations (quality notifications) and Change Management.
Should be able to manage a team of around 8 technicians and engineers.
As a team leader, technicians learning completion, overtime assessment and quarterly one to one are to be handled.
Any other duties as and when assigned by the Manager.
ABOUT YOU:
Degree in Electrical/Electronics,Instrumentation and Control, Mechanical, Mechatronics Engineering
5 - 8 years of related experience in maintenance function, preferably in a sterile manufacturing plant or in a pharmaceutical company.
Sound knowledge of Instruments, valves & other field devices and Programmable Logic Controllers (Siemens S5/S7) with good understanding of the pneumatic control systems.
Good knowledge of cGMP and safety regulations of pharmaceutical industry.
Other Technical Competencies include:
Demonstrates a knowledge of Engineering and Compliance standards.
Competent in the practical application of theoretical engineering knowledge
Demonstrates an understanding of Engineering and other budgets and the importance of working within budgets.
Begins to develop budgets.
Demonstrates an understanding of planning related to assigned engineering role as well as principles /application of risk-based decision cGMP Standards.
In depth understanding of cGMP and WQS standards
Ability to proactively identify and use solutions to ensure an appropriate level of cGMP compliance.
Seeks to contribute to continuous improvements related to cGMP compliance Problem Solving.
Provides solutions which are practical for implementation and highly innovative.
Able to properly assess the situation and understand when to escalate to a higher level.
Competent in root cause analysis, able to analyze information from a variety of sources to make sound decisions.
Working knowledge in SAP and Kneat.
What we look for
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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