Process Automation CSV
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Job Description
About PSC Biotech
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
This role will manage all equipment and system validation activities for the cGMP manufacture of biological bulk drug substances. The Qualification Engineer will provide equipment / system process engineering and validation expertise to support the facility start-up and routine commercial manufacturing.
Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of representatives responsible Process Automation Remediation Plan delivery.
Responsibilities include:
- Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery.
- Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
- Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
- Provide technical support for the development of electronic data review procedures
- Actively manage the execution of all CSV testing with right first time approach.
- Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI s maintained.
Requirements
- At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
- A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
- Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems
Employment Type
Full Time
