Lead Validation Engineer – cGMP & Process Validation

Leadingnation; Hong Kong; On-site; HKD 201,000 - 335,000; Full time

Benefits offered by this job

Free shuttle

Diversified learning opportunities

Rapid growth opportunities

Casual attire

Job summary

Leadingnation is seeking a QA Validation Officer/Engineer in Hong Kong to lead validation activities across facilities, systems, and software. You will collaborate with end users and suppliers, ensure timely completion, and analyze issues for CAPA and Change Control.

The role welcomes fresh graduates and requires strong leadership, English and Cantonese communication, and a proactive, learn‑driven attitude.

Qualifications

• Higher Diploma, Associate Degree or Degree holder in Science, Pharmaceutical, Engineering, or related discipline.
• Good leadership to ensure productive teamwork.
• Good interpersonal skills, hard-working, willing to learn.
• Good language skills in both written and spoken English and Cantonese.
• Fresh graduates are welcome.

Responsibilities

• Lead the validation team and participate in new project initiation, planning, execution and controlling.
• Define and plan qualification/validation activities (including pre- & post-qualification document preparation, impact assessment, communication with equipment/utility suppliers and FAT/SAT engagement where applicable) to meet the cGMP requirements and the required project schedule.
• Coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and / or software.
• Ensure validation activities are completed timely. Analyze validation related issues, implement validation related event, Change Control and CAPA.
• Analyze validation results statistically and write reports summarizing results.
• Perform other related duties within scope of the department.

Skills

Leadership

Interpersonal skills

English & Cantonese

Willingness to learn

Quality assurance

Education

Higher Diploma/Associate Degree/Degree in Science, Pharmaceutical, Engineering

Job description

Leadingnation is seeking a QA Validation Officer/Engineer in Hong Kong to lead validation activities across facilities, systems, and software. You will collaborate with end users and suppliers, ensure timely completion, and analyze issues for CAPA and Change Control.

The role welcomes fresh graduates and requires strong leadership, English and Cantonese communication, and a proactive, learn‑driven attitude.