Senior Engineer, Process Validation - Room for Advancement

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.