Sr. Validation Engineer

A leading organisation in Kuala Ketil is seeking a Sr. Validation Engineer to join their highly skilled Applied Sterilisation Technologies division.

This role offers you the opportunity to become a recognised technical expert in radiation processing validation, supporting both site operations and customer process qualifications. You will be at the heart of a collaborative and knowledgeable team, driving best practices and harmonisation across the site while ensuring compliance with international standards and regulatory requirements. The position provides an engaging blend of hands-on technical work, customer interaction, and team coordination, all within a supportive environment that values continuous improvement, training opportunities, and flexible working arrangements. If you are passionate about quality, enjoy sharing knowledge, and thrive in a setting where your expertise makes a real difference to customers and colleagues alike, this is the perfect next step for your career.

• Become a subject matter expert in radiation processing validation, providing technical guidance and support to both internal teams and external customers throughout all stages of qualification.
• Enjoy a collaborative workplace culture that prioritises teamwork, knowledge sharing, and ongoing professional development through training opportunities and supportive leadership.
• Work in an inclusive environment that values flexibility, continuous improvement, and the satisfaction of delivering exceptional service to customers while adhering to global standards.

What you'll do:

As a Sr. Validation Engineer based in Kuala Ketil, you will play a pivotal role in supporting both site operations and customer process qualifications within the Applied Sterilisation Technologies division. Your day-to-day responsibilities will involve managing complex technical activities related to radiation technology—ranging from dosimetry system oversight to product qualification—and coordinating the efforts of the site’s dedicated radiation technology team. You will be instrumental in evaluating product capabilities through rigorous data analysis, approving critical documentation for qualification processes, and investigating any deviations or nonconformities that arise. In addition to your technical duties, you will facilitate training sessions for both internal teams and customers to foster knowledge sharing and best practice adoption. Your expertise will also be called upon to support innovation initiatives aimed at enhancing facility design or deploying new technologies. Success in this role requires not only strong analytical skills but also excellent interpersonal abilities as you collaborate with colleagues across departments and deliver outstanding service to customers.

• Oversee all technical activities related to radiation technology on site, including dosimetry system management, irradiator qualification, and product qualification processes.
• Organise daily tasks for the site radiation technology team, ensuring effective collaboration and smooth workflow across multiple functions.
• Support customer process qualifications by following technical procedures and work instructions, providing expert guidance during performance qualification activities.
• Evaluate process capability for products before initiating qualification activities and after analysing data to ensure compliance with regulatory requirements.
• Approve protocols, plans, and reports for performance qualification activities while investigating any nonconformities or deviations encountered during these processes.
• Execute dosimetry system qualification, calibration, maintenance activities, and manage laboratory equipment stock to maintain operational excellence.
• Provide technical support to customers and sales teams on performance qualification activities, ensuring their needs are met or exceeded at every stage.
• Facilitate departmental, cross-functional, and customer training sessions to promote best practices and harmonisation within the radiation technology team.
• Support the development of technical procedures and work instructions while assisting the quality team during audits or investigations into non-conformance issues.
• Contribute to technology deployment initiatives by supporting innovation programmes such as simulation modelling or facility design and promoting continuous improvement.

What you bring:

To excel as a Sr. Validation Engineer in Kuala Ketil, your background should include substantial hands-on experience with radiation processing validation under internationally recognised standards such as ISO11137. Your proven ability to apply advanced mathematical concepts—whether through statistical analysis or data-driven decision making—will be essential for evaluating product capabilities and resolving complex problems. You will bring academic knowledge of quality systems like GMP/GDP into practical use within regulated environments where accuracy is paramount. Your interpersonal skills must shine through clear communication with both internal teams and external customers; being able to articulate findings credibly is key. Organisational prowess is vital for managing laboratory resources efficiently while adapting quickly when priorities shift. Above all else, your commitment to customer satisfaction—paired with an inclusive approach towards teamwork—will set you apart as someone who thrives in environments built on mutual respect, shared goals, and continuous learning.

• Demonstrated experience in radiation processing validation aligned with ISO11137 standards over several years within a regulated environment.
• Proven mathematical competence for problem solving including advanced algebra, calculus or statistics applied to organisational or regulatory challenges.
• Ability to complete detailed statistical analysis using MS Office suite alongside specialised statistical tools relevant to validation engineering.
• Academic understanding of quality systems such as GMP (Good Manufacturing Practice) and GDP (Good Documentation Practice), with practical application in previous roles.
• Excellent written and verbal communication skills in English enabling clear expression of ideas while maintaining trustworthiness among colleagues and customers.
• Experience working collaboratively under general supervision as well as independently when required by project demands or changing priorities.
• Strong organisational skills with attention to detail demonstrated through successful management of laboratory equipment stock or calibration schedules.
• Adaptability in responding positively to evolving duties or responsibilities within a dynamic technical environment focused on continuous improvement.
• Customer-focused mindset evidenced by listening attentively to client needs and delivering tailored solutions throughout all stages of validation projects.
• Commitment to teamwork shown by building constructive relationships across departments while effectively managing conflict resolution.

What sets this company apart:

This organisation stands out for its unwavering commitment to safety, quality assurance, innovation, sustainability, lean principles, and customer focus—all delivered through a culture rooted in integrity and mutual respect. Employees benefit from supportive leadership that encourages personal growth through regular training opportunities designed to enhance both technical expertise and soft skills. The company fosters an inclusive atmosphere where everyone’s contributions are valued equally; collaboration is not just encouraged but expected as part of everyday operations. Flexible working arrangements allow you to balance professional ambitions with personal commitments while generous investment in employee development ensures you remain at the forefront of industry advancements. By joining this team you become part of a network dedicated not only to delivering satisfaction for customers but also nurturing success among colleagues through shared knowledge and continuous improvement initiatives.

What's next:

If you are ready to take your career forward as a Sr. Validation Engineer in Kuala Ketil within an environment that values your expertise and supports your growth—apply now!

Apply today by clicking on the link provided or email me at TengHong.Khoo@robertwalters.com.my to discuss this new opportunity!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C