Process Validation

TERUMO (PHILIPPINES) CORPORATION; Quezon City; On-site; PHP 600,000 - 900,000; Full time

Job summary

TERUMO (PHILIPPINES) CORPORATION in Quezon City seeks a full-time Process Validation professional to plan, execute, and document validation activities for medical device manufacturing. You will prepare validation protocols and reports, analyze process data, identify risks, and recommend improvements to ensure product quality and regulatory compliance.

The role requires collaboration with production, engineering, and quality assurance on-site, and participation in audits and maintenance of

Qualifications

• Experience in process validation and validation for manufacturing processes and equipment.
• Knowledge of validation for systems supporting production and quality operations (CSV).
• Proficiency in quality control and quality assurance in regulated environments (medical device/pharma).
• Understanding of ISO 13485, FDA, GMP standards.
• Strong attention to detail and problem-solving; able to collaborate on-site with cross-functional teams.
• Excellent written and verbal communication in English.

Responsibilities

• Plan, execute, and document process validation activities for medical device manufacturing.
• Prepare validation protocols and reports; analyze data and identify process risks.
• Recommend improvements to enhance product quality and regulatory compliance.
• Collaborate with production, engineering, and quality assurance on-site.
• Participate in audits and maintain validation files.

Skills

Process Validation

Manufacturing validation

Process data analysis

Education

Bachelor's degree in engineering, life sciences, or related technical field

Tools

Computer System Validation

Job description

Company Description TERUMO (PHILIPPINES) CORPORATION is a subsidiary of Terumo Corporation, recognized as the leading medical device manufacturer in Japan. Terumo operates 20 factories and 79 sales branches, supplying products to over 150 countries worldwide. The organization is driven by a mission to contribute to society through healthcare and to improve patient outcomes globally. Joining TERUMO (PHILIPPINES) CORPORATION means being part of an international network focused on innovation, quality, and medical advancement. Team members benefit from a professional environment that emphasizes safety, integrity, and continuous improvement.
Role Description This is a full-time, on-site Process Validation role based in Quezon City. The role involves planning, executing, and documenting process validation activities for medical device manufacturing to ensure compliance with internal standards and regulatory requirements. Day-to-day tasks include preparing validation protocols and reports, analyzing process data, identifying process risks, and recommending improvements to enhance product quality and consistency. The role works closely with cross-functional teams such as production, engineering, and quality assurance to support new product introductions and process changes. The position also requires participation in audits, maintenance of validation files, and adherence to company policies and industry guidelines.
Qualifications

• Strong skills in Process Validation and Validation for manufacturing processes and equipment.
• Knowledge and experience in Computer System Validation for systems supporting production and quality operations.
• Proficiency in Quality Control and Quality Assurance practices within a regulated, preferably medical device or pharmaceutical, environment.
• Ability to interpret and apply relevant regulatory standards and guidelines (e.g., ISO 13485, FDA, GMP).
• Bachelor’s degree in engineering, life sciences, or a related technical field.
• Experience with data analysis, statistical tools, and documentation in validation activities.
• Strong attention to detail, problem-solving skills, and ability to collaborate with cross-functional teams on-site.
• Effective written and verbal communication skills in English; ability to prepare clear reports and presentations.