Human Factors / Usability Specialist - Combination Products

A speciality biopharmaceutical company is currently recruiting a Human Factors/Usability Specialist - Combination Products to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

• Leading development projects and documentation thereof from start to finish, including human factors (usability) testing, design verification testing, and product finalization.
• Developing and maintaining technical subject matter expertise in the function and testing of the devices that are part of company combination drug products.
• Developing and maintaining a working knowledge of regulations surrounding combination drug products.
• Drafting source documents for dossier filing, contributing to risk assessments and SOPs.
• Working with QA to maintain Design History File.
• Co-ordinating and maintaining samples for shipment with supply chain.
• Coordinating technical projects with vendors and reviewing all technical documents.
• Coordinating outsourced engineering and assembly activities.

Skills and Requirements:

• At least a BSc, or equivalent, in Engineering, Pharmaceutical Sciences, Biochemistry, or related field. Master's preferred.
• Human factor engineering experience a plus.
• Machinery experience a plus.
• Demonstrable record of managing a project (academic or otherwise) a must.
• Demonstrable experience with statistics.
• Demonstrable ability to work across departments.
• Demonstrable ability to manage projects (academic or industrial).
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Will Hitchcock at +44 203 078 9554 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing 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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