CSV Engineer

Proclinical are recruiting a CSV Engineer for a pharmaceutical organisation. This role is on a contract basis.

Responsibilities:

• You will validate planning for base business, which involves engaging with IT, maintenance automation and quality operations groups.
• Arrange and monitor external subcontractors/software providers when needed.
• Operational management of change controls, CAPAs and non-conformances linked to CSV.
• The ideal candidate will prepare, evaluate, and approve technical and GMP linked documentation such as URS, impact/risk assessment, Master plans, qualification/validation documentation, etc.
• Examine and guide the CSV package(s) on an allocated project.
• Responsible for the work to be generated by self and any other colleagues that are under the designated packages lead by this role.
• Conduct CSV periodic evaluation of equipment and systems.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a technical or natural science field.
• Works well within a fast-altering setting.
• At least 3 years of experience working in a pharma or biotech organisation.
• Familiarity with validating computerised manufacturing equipment.
• Previous involvement in validating software and hardware infrastructure such as servers, network and software services.
• At least 4 years of experience working with CSV.
• Knowledge of CSV needs rendering to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
• Communication skills both verbally and in writing.
• Able to think analytically with the ability to resolve issues.
• Capable of working well while under minimal supervision and under pressure.
• Ability to prioritise workload.
• Works well in a team.
• Fluency in the English language with knowledge in German.
• Familiarity with validating multifaceted computerised analytical equipment such as QC lab equipment.
• Expertise on validation needs rendering to cGMP guidelines.
• Knowledge of quality assurance principles.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at +41 61 508 73 40.

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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