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