Teva Human Factors Engineer 

Ireland 

770059019

• Manage Human Factors (HF)/ Usability and risk management activities associated with combination product development throughout their development cycle.
• Ensure HF processes and procedures are followed according to regulations and best-practice.
• Design and execute formative/validation/comparative use HF studies in accordance with US and EU regulatory guidance.
• Develop user needs, task analyses, cognitive-walk throughs, anthropometric analyses, known use issues, use-related risk assessment and threshold analyses documents.
• Develop intuitive IFUs, labelling artwork and associated language.
• Write HF related technical reports, scientific advice and regulatory submission documents.
• Deliver Customer Service (both internal and external) through project timelines in accordance with quality standards and cost control.
• Identify areas for improvement and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
• Communicate effectively with immediate Line Manager, colleagues and staff from other functions or sections of the Company.
• Ensure that all work carried out is in compliance with the required standards and analysts trained to conform with company, cGMP, cGLP, Health & Safety, Environmental Guidelines and regulatory requirements.
• Participate in the management of projects and where appropriate work cross functionally. Ensure progress is maintained on projects to meet defined project timelines.
• Make comprehensive records of all work and write formal reports. Ensure all appropriate documentation is completed right first time (i.e. correct and in full) in order to achieve Customer Service, GMP and GLP.

Are you...

• Experienced in Human Factors/Usability Engineering and the application of risk management principles, is essential.
• Educated to degree level in a science/engineering/product design related discipline or equivalent
• Experience within the pharmaceutical, medical device or biotech industries is desirable, but not essential.

Do you have…

• Knowledge of Pharmaceutical, Medical Device and/or Combination Product Development Process (Desirable)?
• Familiarity with Human Factors/Usability US and European regulatory guidelines (essential)?
• Computer Skills – Advanced?
• Technical Report Writing Experience?
• Project Management Skills ?
• Strong communication Skills?
• Experience of Authoring/ reviewing/ approving internal and external documents e.g. Protocols/ reports/ equipment qualifications and documents suitable for audits?

Teva designs eligibility to empower and enable employees to manage their careers internally and provides an easy and smooth process to view and apply. To be considered for an open internally posted position, an employee must:

• Be a current employee of Teva
• Meet the basic requirements for the job
• Have received a rating not lower than “Successful” on their most recent performance review and must not currently be on a performance improvement plan
• Apply to the posted requisition within the allotted time frame
• Have been in their current position for a minimum tenure of twelve (12) months

Unless explicitly stated in the job description, no company sponsored work authorisation or relocation assistance should be assumed.

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