全职 Validation Engineer 工作, 薪水, Titanium Systems Johor 公司招聘中 - Ricebowl

Position Summary

The Validation Engineer will be responsible for helping to develop, implement, and oversee validation activities within our ISO 13485-compliant consumable manufacturing facility. The role focuses on validating manufacturing processes, equipment, and systems to ensure that they consistently produce products that meet all regulatory, safety, and quality requirements. The ideal candidate will play a key role in maintaining compliance with ISO-13485 standards, ensuring that all validation processes are thoroughly documented, executed, and reported. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

Execute process validation and equipment validation in accordance with ISO-13485 standards.

Assist in developing and executing Validation Master Plans (VMP), Validation Protocols, and Validation Reports for all validation activities.

Conduct risk assessments to determine critical process parameters and establish control limits for process validation and verification.

Validate manufacturing processes to ensure consistent production of consumables that meet established quality standards.

Assist in the creation and execution of Process Performance Qualification studies

Work closely with the production and engineering teams to identify areas for improvement in manufacturing processes, including optimizing parameters and ensuring robustness and consistency in results.

Maintain accurate and detailed records of validation activities, including protocols, reports, and supporting documentation.

Review and approve validation documentation and reports to ensure compliance with internal standards and regulatory requirements.

Participate in internal and external audits to assess the effectiveness of validation activities and ensure regulatory compliance.

Address findings from audits or inspections related to validation, ensuring that corrective actions are implemented and documented.

Participate in cross-functional teams to improve product quality, operational efficiency, and validation practices.

Stay up-to-date with the latest developments in validation techniques, regulations, and industry standards.

Requirements :

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related field

Minimum of 3-5 years of experience in a Validation Engineering or Validation Engineer role with ISO 13485-compliant medical device or regulated manufacturing environment experience.

Proven experience with process validation, equipment qualification, and regulatory compliance.

Strong problem-solving and analytical skills

Effective communication skills, both verbal and written

Self-awareness, integrity, authenticity, and a growth mindset Preferred Skills/Experience

Strong understanding of quality control principles and supplier management practices.

Proficiency in audit techniques, supplier performance tracking, and data analysis.

Familiarity with ISO-13485 Quality Management Systems (QMS