Device Technical Manager

Highly Competitive
  1. Permanent
  2. Data Management
  3. Iceland
Iceland
Posting date: 20 Nov 2020
30411

A privately owned, fully integrated specialty biopharmaceutical company is looking for a talented Device Technical Manager. This role is exclusively focused on the development and manufacturing of high-quality biosimilar products. This organisation is well on its way to becoming a global leader in the biosimilar space. This organisation already has a powerful group of people that are experts in their fields, this would be the perfect opportunity to join them and excel in your chosen field.

Job Responsibilities

  • Leads their development project and documentation thereof from start to finish including human factors (usability) testing, design verification testing, and product finalization.
  • Develop and maintain technical subject matter expertise in the function and testing of the devices that are part of the organisation combination drug product.
  • Develop and maintain a working knowledge of regulations surrounding combination drug products.
  • Draft source documents for dossier filing, contribute to risk assessments and SOPs
  • Works with QA to maintain Design History File.
  • Co-ordinates and maintains samples for shipment with supply chain.
  • Day to day coordination of technical projects with vendors and reviews all technical documents
  • Coordinates outsourced engineering and assembly activities.

Skills and Requirements

  • MSc. Preferred. BSc. Equivalent minimally. Engineering, pharmaceutical sciences, biochemistry or related field.
  • Human factor engineering experience a plus. Machinery experience a plus. Demonstrated record of managing a project (academic or otherwise) a must. Demonstrated experience with statistics.
  • The candidate must have a demonstrated ability to work across departments.
  • The candidate must have a demonstrated ability to manage projects (academic or industrial).
  • The candidate must be organized, take initiative, be prepared to challenge and have strong communication skills.
  • An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.
  • An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
  • It is important that an employee has the company values at heart in his/her work.
  • An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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