Validation Engineer / Senior Validation Engineer

Validation Engineer/ Senior Validation Engineer

Job Description

Responsibilities:

·         Perform routine validation activities related to Manufacturing/Packaging Process Validation, Equipment Qualification and/ or Cleaning Validation.

·         Ensure that validation procedures are followed and templates are consistently utilized to generate related documents.

·         Prepare protocol and report in a timely manner and in compliance with the Validation Master Plan and Quality Management Systems (i.e., Change Control, Risk Assessment or CAPA).

·         Execute the protocol/ perform tests and collate data/ test results.

·         Perform Periodic Reviews and/ or Routine Monitoring based on approved procedures and schedule.

·         Update regular validation schedules & registers.

·         Report to Validation Manager and work closely with cross functional departments (i.e., Production/ Engineering/ QA/ QC).

·         Assist in ad-hoc tasks assigned by Validation Manager.

Qualifications:

·         Higher Diploma/ Bachelor degree in Electrical/ Chemical/ Mechanical/ Quality Engineering or pharmaceutical, chemical science or biological related discipline.

·         At least 1 year related experiences in Pharmaceutical/ Medical Device/ Life Science Industry.

·         Possess knowledge on preparation of process validation protocol/ report and have good documentation skill.

·         Ability to analyze test results and data.

·         General knowledge of quality system, validation, pharmaceutical production processes and equipment.

·         Must be familiar with GMP / PIC/S / Other regulatory requirements.

·         Good command of spoken and written English and Chinese

·         Hardworking, honest, cooperative and flexible in working, interacting and communicating with diverse individuals/ groups.

·         Proficiency in PC applications, including MS Office

·         Willing for continuous learning and improvement.

·         Candidates with more experience will be considered as Senior Validation Engineer

免費穿梭巴士

(地點: 上水, 粉嶺, 荃灣, 大埔, 沙田, 屯門, 元朗, 九龍塘, 觀塘, 九龍灣, 柴灣, 太古, 天水圍)