- Baling, Kedah Baling Kedah Malaysia
工作地点
职位描述
岗位职责
About the role
Synergy Sterilisation (M) Sdn Bhd is seeking a talented Senior Validation Engineer to join our dynamic team in Kuala Ketil, Kedah. As a full-time position, you will play a crucial role in ensuring the integrity and compliance of our sterilisation processes and equipment. Your expertise will be instrumental in upholding the highest standards of quality and safety in the pharmaceutical and medical device industries.
What you'll be doing
Developing and executing validation protocols for sterilisation processes, equipment, and associated systems
Analysing validation data and producing comprehensive reports to demonstrate process capability and compliance with regulatory requirements
Providing technical expertise and guidance to cross-functional teams on validation and qualification activities
Collaborating with project managers, engineers, and quality assurance personnel to identify and resolve validation-related issues
Staying up-to-date with industry regulations, guidelines, and best practices, and ensuring the company's validation practices align with these standards
Mentoring and training junior validation engineers to develop their skills and knowledge
What we're looking for
A Bachelor's Degree in Engineering, with a focus on Biomedical, Mechanical, or Chemical Engineering
Minimum 5 years of experience in a validation role within the pharmaceutical or medical device industry
Demonstrated expertise in the design, development, and implementation of validation protocols for sterilisation processes and equipment
Strong understanding of relevant regulations and guidelines, such as FDA, ISO, and GMP
Excellent problem-solving, analytical, and critical thinking skills
Exceptional written and verbal communication skills, with the ability to present complex technical information to diverse stakeholders
Proficiency in data analysis and report writing
Experience in leading and mentoring a team of validation engineers
What we offer
At Synergy Sterilisation, we pride ourselves on fostering a collaborative and supportive work environment. We offer a competitive salary, comprehensive benefits package, and opportunities for professional development. Our state-of-the-art facilities and commitment to innovation provide an exciting and challenging workplace for talented individuals like you.
If you're ready to take on a rewarding role and make a valuable contribution to our company, we encourage you to apply now.
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