Validation Technician

Synergy Sterilisation (M) Sdn Bhd; Kuala Ketil; On-site; MYR 180,000 - 280,000; Full time

Job summary

CANTEL MEDICAL (MALAYSIA) SDN.BHD. seeks a Senior Validation Manager to oversee validation programs, ensure ISO 11135 alignment, and coordinate cross-functional teams across quality, operations, and planning. You will liaise with customers and auditors to drive compliant outcomes.

The role requires steering validation cycles, training and mentoring validation staff, and implementing corrective actions to prevent non-conformances. Strong leadership and quality systems focus are essential.

Responsibilities

• Coordinates validation cycles, reviews, and approves validation protocols, reports and CSPs.
• Liaises with quality, operations, planning, laboratory and Customer service to progress validations and projects to completion.
• Supports and facilitates internal/external audits by Customers, notified bodies and Regulators; acts on audit findings.

Job description

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.

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

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.

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

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

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

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

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.

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.

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.

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.

Other site specific duties as defined by Senior Validation Manager.

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.

Facilitates the training, development and mentoring of Validation Engineers and Validation Assistant.

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

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.

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.

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.

Manufacturing, Transport & Logistics 11-50 employees

CANTEL MEDICAL (MALAYSIA) SDN.BHD.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services.

CANTEL MEDICAL (MALAYSIA) SDN.BHD.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services.