Senior Technician, Validation (Pharmaceutical Manufacturing)

Senior Technician, Validation

Location: Glenmarie, Selangor
Company: Duopharma HAPI Sdn Bhd

Job Summary

We are looking for a motivated and detail-oriented Senior Technician, Validation to join our Validation team. The role is responsible for executing qualification and validation activities in accordance with the Validation Master Plan, regulatory requirements, and company standards within a GMP-regulated pharmaceutical manufacturing environment.

Key Responsibilities

Validation & Qualification

• Execute qualification and validation activities according to the approved Validation Master Plan.
• Perform periodic re-evaluation of validated and qualified systems.
• Execute method validation, performance qualification (PQ), temperature mapping, cleaning validation, and computerized system validation (CSV) activities.
• Perform testing of validation samples and ensure results are properly documented.
• Support validation and qualification activities in accordance with applicable GMP requirements.

Documentation & Compliance

• Prepare and maintain validation and qualification documentation.
• Act as the Documentation Controller for the Validation Department.
• Ensure validation records and supporting documents are complete, accurate, properly controlled, and securely maintained.
• Ensure all validation activities comply with GMP and GLP requirements.
• Support document preparation and validation-related testing in the absence of the Executive, Validation.

Cross-Functional Collaboration

• Coordinate with Production, Quality Control (QC), and Quality Assurance (QA) teams to ensure validation activities are executed and completed according to schedule.
• Work closely with relevant departments to facilitate smooth execution of qualification and validation activities.
• Support the Validation team in meeting project timelines and regulatory requirements.

Requirements

Qualifications

• Diploma or Bachelor's Degree in Science, Chemistry, Pharmaceutical Science, Biotechnology, Engineering, or a related discipline.

Experience

• Experience in pharmaceutical manufacturing, validation, qualification, or a GMP-regulated environment will be an advantage.
• Candidates with relevant laboratory or pharmaceutical validation experience are encouraged to apply.

Note: The existing JD does not specify a minimum years of experience or a specific academic qualification; therefore, I have kept the JobStreet requirements broad rather than inventing a requirement.

Technical Skills & Knowledge

• Hands-on experience with High Performance Liquid Chromatography (HPLC) is an advantage.
• Good knowledge of GMP and GLP requirements.
• Good understanding of validation and qualification principles.
• Strong data analysis and documentation skills.
• Good analytical and problem-solving abilities.
• Good communication skills.

Key Competencies

• Highly motivated and proactive.
• Result-oriented with strong ownership of assigned activities.
• Strong attention to detail and accuracy.
• Good analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• Able to coordinate effectively with multiple departments.

The original JD specifically identifies high motivation and a result-oriented approach as key behavioural competencies.

Why Join Us?

• Gain hands-on experience in pharmaceutical validation and qualification activities.
• Work across Production, QC, QA, and other technical functions.
• Gain exposure to cleaning validation, temperature mapping, computerized system validation, method validation, and performance qualification.
• Develop your technical expertise within a GMP-regulated pharmaceutical manufacturing environment.
• Build your career within Duopharma HAPI Sdn Bhd.