Validation Specialist - CSV

Hobson Prior are currently seeking for a Validation Specialist - CSV to join a brilliant pharmaceutical establishment on a contract basis located in Bern. Our client is focused on changing illnesses into a manageable situation.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for the work generated by self and other personnel that are under the allocated packages lead by this role.
• Evaluate and guide the CSV package(s) on allocated projects.
• Conduct CSV period evaluation of equipment and systems.
• You will operationally handle change controls, CAPAs and non-conformances linked to CSV.
• Plan, evaluate and sanction technical and GMP connected documentation such as URS, impact/risk assessment, Master plans, qualification/validation documentation.
• Organise and supervise external subcontractors/software providers.
• The ideal candidate will guarantee the CSV procedure linked processes and life cycle management are kept up to date rendering to global GMP standards and processes internally.
• Assist the technical services division KPI.
• Manage the validation planning for base business which involves engaging with IT, Maintenance Automation and Quality Operations groups.
• Any other assigned duties.

Key Skills:

• Communication skills both verbally and in writing.
• Able to think analytically and resolve issues.
• Capable of working under minimal supervision with the ability to evaluate priorities as well as work well under pressure within a fast-paced work setting.
• Able to work well in a multidisciplinary, global team.

Requirements:

• Educated to a degree level in a technical or natural science discipline.
• Capable of working within a fast-changing setting.
• At least 3 years of experience working within a pharma or biotech organisation.
• Prior involvement in validating computerised manufacturing equipment (CSV context).
• Familiarity with 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 directives and ISPE GAMP 5 regulations.
• Fluency in the English language with knowledge in German.
• Acquaintance with validating multifaceted computerised analytical equipment.
• General knowledge of qualification needs rendering to cGMP guidelines.
• Knowledge of quality assurance principles.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.