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Validation Engineer - Taiwan or Wuhan

Summary

 Full time position responsible for qualification and validation of the global-standard JHL Biotech facilities  in China.  This function will cover the JHL-1 commercial facility and Development Laboratory:

·         Active participation in compliance and continuous improvement of the Company Quality Management System with specific attention to validation lifecycle processes.

·         Member of the cross-functional Engineering and Validation Department.

·         Qualification and Validation of company equipment and processes.

  • General support of cross-functional Engineering Department.

Job Responsibilities

Essential functions include, but are not limited to the following:

·         Site Safety

o   Contributing to the safe operation of JHL Biotech facilities through personal initiative and adherence with Company procedures.

o   Zero lost-time injuries

·         Qualification and Validation

o   Maintaining the validated state of direct-impact systems in compliance with Good Manufacturing Practice (GMP).

o   Review of Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors.

o   Preparing validation plans and protocols: DQ, IQ, OQ, and PQ

o   Coordinating preparation of Process, Cleaning, and Computerized System Validation Plans in collaboration with Subject Matter Experts.

o   Validation of qualification and validation protocols in compliance with Good Documentation Practice and approved procedures.

o   Preparation of validation reports.

o   Selection and purchase of equipment and consumables required to execute validation activities.

·         Quality

o   Preparing standard operating procedures and associated records covering the validation lifecycle: risk assessments, URS, FS, DS, Qualification Protocols, Reports, Protocol Execution.

o   Preparing standard procedures for operation of testing equipment used in validation testing such as KAYE 2000 thermal mapping systems.

o   Raising and timely closure of Qualification Deviations.

o   Identify validation requirements for proposed changes and corrective actions.

o   Complying with, and continuously improving, the Company QMS.

·         Design

o   Draft system- and component-criticality assessments.

o   Facilitate validation risk assessment workshops to document failure modes and mechanisms for control of critical-to-quality attributes.

o   Reviewing specifications for compliance with company quality standards and performance criteria.

·         Management

o   Providing technical and financial input to capital expenditure requests for site improvement and renovation projects.

o   Supervising specialist validation contractors.

o   Preparing weekly and monthly progress reports.

o   Represent validation in tech transfer of validation processes and systems between sites.

Contributing positively to Company morale.

Job Qualifications (Education, Certifications, Experience)

                        o   B.E. (preferably Mechanical or Chemical) plus a minimum of 2 years of experience in validation within pharmaceutical or medical device industries

o   or at least 5 years of industry experience in validation without formal qualifications.

o   Preferably experienced in operation of pharmaceutical facilities with exposure to facility start-up.

o   Sound knowledge of Good Engineering Practices encompassing documentation and operation of pharmaceutical facilities.

o   Sound Understanding of Good Manufacturing Practice (GMP).

o   Familiar with Good Automated Manufacturing Practice (GAMP).

o   Sound knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and cleanroom HVAC), computerized systems, process equipment, and analytical test equipment.

o   Advanced document writing skills using MS Office suite.

o   Eye for detail and preference to work in highly structured manner.

o   Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.

o    Ideally hands-on experience in thermal mapping of controlled temperature environments and qualification of computerized systems.

Preferably Member of ISPE or PDA