Senior Engineer Industrial IT - CSV
Posted on Mar 22, 2022 by Michael Bailey Associates - UK Contracts
A major pharmaceutical company is searching for; Senior Engineer Industrial IT - CSV
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
o Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
o Validation Master plans are up to date and established for all ongoing projects
Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
Ensuring completion of CSV Periodic Review activities and assessment of the required corrective actions
Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
Coordination and oversight of external subcontractors/software suppliers
Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV
Support Technical Services department KPI.
Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures
Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment/computerized systems commissioning and qualification process are assessed and resolved.
Bachelor/master's degree in technical or natural sciences
A minimum of 3 years of working experience within pharma or a biotech company
Profound know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines
Basic know-how of Qualification requirements according to cGMP regulations
Proven track record of leading and executing CSV validations on manufacturing equipment and higher-level systems (ISA-95 2 and 3)
Experience on CSV validation for infrastructure systems (eg: networkwide services, network infrastructure and virtualization)
Previous technical experience with IT or automation systems is desired.
Experience on CSV validation of analytical equipment is a plus.
Basic know-how of quality assurance principles
Experience with CAPAs
Structuring and definition of CSV tests in order to comply with company guidelines
Business fluency in English
German language preferred
Michael Bailey International is acting as an Employment Business in relation to this vacancy.