Validation Engineer

Cochlear Limited; Kuala Lumpur; On-site; MYR 78,120 - 122,760; Full time

Job summary

Cochlear Malaysia is seeking a Validation Engineer to support manufacturing validation activities. You will work with Process Engineering, Manufacturing Engineering, Quality Engineering, Software Validation, and Design to ensure products meet quality and regulatory standards.

Ideal candidates have 3–5 years in V&V, strong knowledge of IQ/OQ/PQ, GDP, and QMS. A regulated manufacturing background in medical devices or semiconductor industries is highly regarded.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Industrial or related engineering.
• 3–5 years in Validation & Verification, Process Validation or similar in regulated manufacturing.
• Experience in medical device/pharmaceutical/semiconductor industries preferred.
• Good understanding of QMS and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820).

Responsibilities

• Plan, execute and review validation activities for processes, equipment, test methods and facilities.
• Support design transfer and new equipment installations into manufacturing.
• Prepare and review validation protocols, plans, reports and IQ/OQ/PQ docs.
• Ensure validation activities comply with QMS and regulatory standards.
• Maintain traceability between design requirements and validation throughout lifecycle.
• Collaborate with cross-functional teams to provide validation guidance.
• Support investigations, NCRs, and CAPAs; assess changes to maintain validated systems.
• Monitor regulatory requirements and seek continuous improvement in validation.
• Build strong relationships with local and global stakeholders.

Skills

V&V

IQ/OQ/PQ

GDP

Risk analysis

Cross-functional collaboration

Regulatory understanding

Education

Engineering degree (Mechanical / Chemical / Industrial)

Tools

GDP

Job description

## Validation EngineerApplylocations: Kuala Lumpurtime type: Full timeposted on: Posted Todayjob requisition id: R-623776Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.**The Opportunity**Join Cochlear Malaysia as a **Validation Engineer** and play an important role in supporting the quality and compliance of our manufacturing operations. As we continue to grow, you'll support validation activities for manufacturing processes, equipment, test systems, transport, and facilities, helping to ensure our products meet the highest quality and regulatory standards.Working closely with cross-functional teams including Process Engineering, Manufacturing Engineering, Quality Engineering, Software Validation, and Design, you'll support design transfer, new equipment installation qualification and continuous improvement initiatives. You'll also collaborate with colleagues across our global manufacturing network in Brisbane and Sydney to deliver compliant, high-quality outcomes.This is a great opportunity for validation professionals from the medical device, pharmaceutical or semiconductor industries who enjoy working in a regulated manufacturing environment and making a meaningful impact.**Key Responsibilities:*** Plan, execute and review validation activities for manufacturing processes, equipment, test methods, test systems, transport and facilities.* Support design transfer activities, including new equipment installations, equipment transfers, and implementation into manufacturing.* Prepare and review validation documentation, including validation plans, protocols, reports, risk assessments and IQ/OQ/PQ qualification documents.* Ensure validation activities comply with Cochlear's Quality Management System (QMS), regulatory requirements and industry standards.* Support verification and validation activities by maintaining traceability between design requirements and validation throughout the product lifecycle.* Partner with cross-functional teams to provide validation expertise, technical guidance and support across projects.* Support investigations relating to validation, NCRs, and CAPAs and assess process or equipment changes to maintain validated systems.* Monitor regulatory and quality requirements, identify opportunities for continuous improvement and help strengthen validation processes.* Build strong relationships with local and global stakeholders while contributing to project, manufacturing and quality initiatives.**Position-Specific Skills and Challenges*** Experience in process validation, verification & validation (V&V) and equipment qualification within a regulated manufacturing environment.* Strong understanding of the validation lifecycle, including IQ, OQ, and PQ, with the ability to apply validation principles across manufacturing projects.* Ability to develop clear technical documentation, including validation protocols, reports and quality records in line with Good Documentation Practices (GDP).* Strong analytical and problem-solving skills, with experience applying risk-based approaches and root cause analysis tools such as 5 Whys.* Excellent communication and stakeholder management skills, with the ability to provide technical guidance and work effectively across cross-functional teams.* Well-organised and able to manage multiple priorities while maintaining compliance and delivering quality outcomes.**Qualifications & Experience*** Bachelor's degree in Mechanical, Chemical, Industrial or a related Engineering discipline.* 3–5 years' experience in Validation & Verification (V&V), Process Validation or a similar role within a regulated manufacturing environment.* Experience in the medical device, pharmaceutical or semiconductor industry will be highly regarded.* Experience supporting validation activities across the product lifecycle, including design transfer, equipment qualification (IQ/OQ/PQ), process validation and manufacturing support.* Good understanding of Quality Management Systems (QMS), Design Controls and validation principles.* Working knowledge of relevant regulatory standards, including ISO 13485, ISO 14971, FDA 21 CFR Part 820, and cGMP/Good Manufacturing Practices.* Experience preparing and reviewing validation documentation, including protocols, reports, qualification documents, and risk assessments, with knowledge of Good Documentation Practices (GDP).* Knowledge of risk management, root cause analysis, and continuous improvement methodologies; experience with NCRs, CAPAs, or audits will be an advantage.* Strong communication, collaboration and organisational skills, with the ability to work effectively across cross-functional teams.Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.