CSV Engineer

Hobson Prior are currently looking for a CSV Engineer to join a fantastic pharmaceutical organisation on a permanent basis located in Neutchetal. Our client is focused on implementing forward-looking practices to help as many people as possible.

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 conduct investigations affiliated to validation actions such as aberrations or OOS during validation studies.
• Guarantee safe and compliant cGMP operations.
• Perform training for internal clients on protocols affiliated with equipment, systems, and procedures under validation.
• Upkeep permanent inspection promptness and actively assist regulatory inspections.
• You will develop the protocols for validation, re-qualification and revalidation of equipment/system and system linked to.
• Assist the tracking the team metrics and handle accomplishment of goals and projects.
• Offer technical contributions and investigation assistance for validation linked investigations, guaranteeing compliance with validated state of the procedure.
• Any other assigned duties.

Key Skills:

• Acquaintance with collaborating with external associates and/or guiding a cross-functional team.
• Communication skills both verbally and in writing, with the ability to inspire at all levels of the department.
• Able to think tactically as well as translate methods into actions.
• Capable of prioritising workload and offer clear guidance to team members within a highly energetic team.

Requirements:

• Educated to an advanced degree level in an engineering, technical or similar field or corresponding experience.
• At least 3 years of experience in validation of system (CSV).
• Know-how of global regulatory guidelines, cGxP needs and best practices, which involves 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP regulations and GAMP.
• CSV, automation and data integrity process knowledge.
• Practical familiarity with new MES System, manufacturing software.
• Fluency in the English and French languages.

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.