CSV Engineer, Computer Systems Validation (CSV)
JHL Biotech新竹市Update time: September 14,2019
Job Description
Job Responsibilities
Maintaining JHL CSV policies and procedures to align with GAMP, PDA and PIC/S guidance.
Collaborating with GMP functional departments to ensuring the computer systems are validated in accordance with JHL CSV policies and procedures.
Providing guidance for validation activities of computer systems to functional SMEs.
Representing as the CSV Subject Matter Expert during the regulatory audits.
Representing as the CSV lead in the IT GMP systems projects to ensuring that the GMP projects implementation and deliverables meeting JHL CSV policies and procedures. GMP systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Learning Management System (LMS) etc.
Preparing and reviewing of CSV documents e.g. validation plan, URS, specifications, testing protocols and reports and validation summary report and associated SOPs, deviations and change controls and assessments.
Conducting training for the computer systems validation general awareness and processes.
Working with GMP functions to ensure they are inspection ready for their regulated computer systems and also conducting internal audits on the computer systems to ensure compliance.
Working with vendors to ensure their deliverables complies with JHL’s policies and procedures.
Supporting the existing computer systems periodic reviews and remediation activities.
Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
Job Qualifications (Education, Certifications, Experience)
2 to 5 years’ CSV or validation working experience in a regulated environment. Working experience in the pharmaceutical or medical device industries is an added advantage.
Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
The ability to effectively prioritize and manage multiple project workloads.
Good communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions.
Good interpersonal and teamwork skills.
Maintaining JHL CSV policies and procedures to align with GAMP, PDA and PIC/S guidance.
Collaborating with GMP functional departments to ensuring the computer systems are validated in accordance with JHL CSV policies and procedures.
Providing guidance for validation activities of computer systems to functional SMEs.
Representing as the CSV Subject Matter Expert during the regulatory audits.
Representing as the CSV lead in the IT GMP systems projects to ensuring that the GMP projects implementation and deliverables meeting JHL CSV policies and procedures. GMP systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Learning Management System (LMS) etc.
Preparing and reviewing of CSV documents e.g. validation plan, URS, specifications, testing protocols and reports and validation summary report and associated SOPs, deviations and change controls and assessments.
Conducting training for the computer systems validation general awareness and processes.
Working with GMP functions to ensure they are inspection ready for their regulated computer systems and also conducting internal audits on the computer systems to ensure compliance.
Working with vendors to ensure their deliverables complies with JHL’s policies and procedures.
Supporting the existing computer systems periodic reviews and remediation activities.
Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
Job Qualifications (Education, Certifications, Experience)
2 to 5 years’ CSV or validation working experience in a regulated environment. Working experience in the pharmaceutical or medical device industries is an added advantage.
Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
The ability to effectively prioritize and manage multiple project workloads.
Good communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions.
Good interpersonal and teamwork skills.
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