CSV Engineer

Proclinical are recruiting a CSV Engineer for a pharmaceutical organisation. This role is on a contract basis and is located in Bern. The client is focused on formulating a healthier community.

Responsibilities:

• Guarantee the accomplishment of CSV Periodic Review actions and evaluation of the necessary corrective activities.
• Manage the formulation of validation for base business which involves interaction with IT, Maintenance Automation and Quality Operations teams.
• Participate to guarantee that modifications inducted in the establishment of systems, processes and formulas are handles so all features of the equipment/computerised systems commissioning, and qualification procedure are examined and solved.
• Organise and supervise external subcontractors/software providers.
• You will warrant the CSV procedure linked processes and life cycle management are up to date rendering to internal GMP standards and internal processes.
• Manage change controls, CAPAs, and non-conformances connected to CSV.
• Prepare, organise and implement all stages for computerised system validation of production and QC lab systems which may involve Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
• Comprehend client requirements and outline electronic archives needs for computerised system following guidelines and company standards.
• The ideal candidate will organise and implement FAT/SAT, commissioning actions focused on CSV for new systems, cooperating with associates on an internal and external level.
• Plan, assess, and sanction technical and GMP correlated reports such as URS, impact/risk assessment, Master plans, qualification/validation documentation.
• Assist the Technical Services division KPI.

Skills & Requirements:

• Educated to a degree level in a technical or natural science discipline.
• Capable of operating within a fast-altering setting.
• At least 3 years of experience within a pharma or biotech industry.
• Validating computerised manufacturing equipment experience such as CSV context.
• Familiarity with validating software and hardware infrastructures such as servers, networks and software services.
• At least 4 years of experience with CSV.
• Knowledge of CSV needs rendering to FDA 21CFR part 11/EUGMP Annex 11 guidelines and ISPE GAMP 5 regulations.
• Communication abilities.
• Able to think analytically and resolve issues.
• Capable of operating under minimal supervision with the ability to examine priorities and well under pressure within a fast-paced setting.
• Work well in a multidisciplinary, global team.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Sasha Botha at +41 61 568 79 88.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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