• Senior Engineer/ Process Validation - Room for Advancement Kuala Lumpur
  • Technocom Systems Sdn Bhd in Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
  • jobs
  • 4 weeks ago

jobs description

We are in need of a versatile Senior Engineer, Process Validation to join our energetic team at Technocom Systems Sdn Bhd in Tebrau, Johor.
Growing your career as a Full time Senior Engineer, Process Validation is an awesome opportunity to develop critical skills.
If you are strong in strategic planning, leadership and have the right vision for the job, then apply for the position of Senior Engineer, Process Validation at Technocom Systems Sdn Bhd today!

Job Responsibilities:
• Lead validation projects and complete all associated project documentation in line with regulatory expectations;
• Develop and maintain masterlist of new and existing computerised system in the factory.
• Manage, coordinate and guide the execution of the site validation master plan;
• Provide the relevant support for regulatory audits, submissions and other auditor requests;
• Populate validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary... output is and if it is meeting predefined criteria);
• Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, environmental, etc;
• With SME support, develop and write commissioning, qualification and validation documents following established standards and templates;
• Ensure the validation status of equipment and systems are in compliance with cGMPs at all times;
• Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments;
• Maintain validation documentation through the validation lifecycle;
• Provide evidence of both internal and external regulatory compliance
• Ensure accurate records of all validation activities;
• Supervise junior staff or management of a team of validation professionals;
• Participate in any special projects/programs as & when assigned by Company.

Education and Experience:
• Degree in Mechanical / Mechatronics / Manufacturing / Electronics / Electrical Engineering or equivalent;
• Preferably with 5 - 7 years relevant experience in a highly competitive manufacturing environment.

Job Related Skills
• Understanding of process control, product and process configuration and computer knowledge is an added advantage;
• Machine operation, maintenance and troubleshooting skills is advantageous;
• Resourceful, responsive, reliable and ability to interact with people at all levels;
• Good interpersonal, teamwork, written and verbal communications.

Benefits of working as a Senior Engineer, Process Validation in Tebrau, Johor:

● Excellent benefits
● Continuous Learning Opportunities
● Advantageous package

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Kuala Lumpur Federal Territory of Kuala Lumpur Malaysia


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