Senior Validation Engineer

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:

1. Collaborates with the Customers throughout all stages of their Validation projects to establish cycle process parameters in line with SEO and in compliance with ISO 11135. Coordinates validation cycles, reviews, and approves validation protocols, report and CSPs etc. within agreed timeliness.

2. Liaises with quality, operations, planning, laboratory and Customer service to coordinate and progress Customer validations and projects to successful completion.

3. Prepares for, supports and where necessary facilitates both internal and external audits conducted by Customers, notified bodies and Regulatory Agencies. Takes appropriate action on assigned audit findings to implement effective corrective action.

4. Conducts internal audits of the quality management systems as scheduled and reports all audit findings, observation, or recommendation for improvement.

5. Schedules, documents and coordinates commissioning and recommissioning of sterilisation chambers.

6. Provides and facilitates departmental, cross functional and Customer training in areas of technical expertise.

7. Maintains professional skills and knowledge by attending education workshops, reviewing professional publications and participating in professional forums and conferences.

8. Contributes and performs in compliance with STERIS core values, STERIS code of business conduct and STERIS initiatives to meet corporate goals and objectives. Adheres with Global Work Instructions, local Policies and Procedures.

9. Communicates in an effective manner, collaborates with all STERIS employees, Customers, auditors and visitors to the site in a professional, courteous and respectful manner providing timely and accurate responses. Encourages the sharing and exchange of ideas and removal barriers to achieve common objectives.

10. Aware of Health and Safety requirements, complies with safety policies and procedures. Promptly reports any observed breaches or risks to the Health and Safety representative.

11. Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions. Documents and files training records and certifications.

12. Other site-specific duties as defined by Senior Validation Manager.

13. Acts as a designate for the Senior Validation Manager, provides guidance and direction to the Validation Team. Promotes and encourages teamwork and positive team morale.

14. Facilitates the training, development and mentoring of Validation Engineers and Validation Technicians.

15. Implements and manages change as per change control processes in compliance with STERIS Quality Management system.

16. In partnership with the Senior Validation Manager and Site Quality Manager identifies, initiates and implements effective corrective actions to prevent non-compliances and/or reoccurrence of non-conformances.

17. Accepts additional responsibilities and project management opportunities within the EO Technical department. Facilitates EMEA cross site collaboration on projects, Global work instructions, EMEA harmonization and STERIS initiatives.

18. Collaborates and proactively supports the Senior Validation Manager to achieve STERIS goals and objectives. Encourages the exchange of ideas, identifies opportunities for improvement and implements appropriate solutions in line with best practice.

What we're looking for

1. A Bachelor's Degree in Engineering, with a focus on Biomedical, Mechanical, or Chemical Engineering
2. Minimum 5 years of experience in a validation role within the pharmaceutical or medical device industry
3. Demonstrated expertise in the design, development, and implementation of validation protocols for sterilisation processes and equipment
4. Strong understanding of relevant regulations and guidelines, such as FDA, ISO, and GMP
5. Excellent problem-solving, analytical, and critical thinking skills
6. Exceptional written and verbal communication skills, with the ability to present complex technical information to diverse stakeholders
7. Proficiency in data analysis and report writing
8. 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.