Validation Engineer - Taiwan or Wuhan
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.
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.
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.
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.
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