Senior CSV Engineer

An excellent contract opportunity has opened for a Senior CSV Engineer to join An award-winning biopharmaceutical organisations. This role will be on a contract basis and located in Geneva.

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

Job Responsibilities:

• Complete the execution and documentation of the CSV Program. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
• Ensure project deadlines and performance standards are met while communicating status; accordingly, respond to inquiries from management, end users and clients, and provide status updates on a frequent basis
• Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab and manufacturing systems.
• Work collaboratively to ensure the development of CSV best practices and promulgation to site CSV employees to support the timely delivery of validated computer systems for internal clients.
• Keep current of trends, new products and technologies, and regulatory requirements that may have an impact on CSV. Serve as the CSV SME during audits and for any standards.

Key Skills:

• Ability to read, analyze, and interpret complex documents.
• Conveys information clearly and concisely, both orally and in writing.
• Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers in order to understand situations and to perform their assignments.
• Interfaces professionally, effectively, and efficiently with all levels of management, coworkers, and outside vendors.

Requirements:

• BS, MS or PhD in an Information Technology discipline and/or 5-7 years of industry experience.
• Lab equipment validation knowledge and experience is required.
• Exposure to IT computer validation and alignment of IT validation with other validation requirements.
• Knowledge of biotech manufacturing obtained from cGMP facility
• Demonstrated project management ability with good written and oral communication skills is required.

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.