Senior Scientist/Engineer

Job Summary

In this role, you will assist engineers and scientists with a variety of laboratory tasks. This includes performing chemical and/or physical analyses or scientific tests using both routine and special techniques in compliance with all safety, infection control standards and - in case of computerized systems data integrity requirements. You will collect, analyze and process laboratory samples, record results of tests, organize data, and prepare reports and analyses using standard procedures and guidelines.

Essential Duties and Responsibilities

• Perform analysis using various techniques including established and experimental test methods.
• Be an expert on performance and interpretation on the various techniques available in the laboratory and make recommendations for improvements.
• Use instrumentation both qualitatively and quantitatively where appropriate.
• Develop and validate methods for Instron and Zwicks.
• Manage projects from protocol to final report, including data release as required.
• Train analysts.
• Keep current with new analytical technology and research/recommend acquisitions where appropriate.
• Author technical papers that are suitable for publication.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques.
• Prepare work instructions, SOPs, and qualification documentation.
• Design lab studies and prepare study plans and protocols.
• Interact with internal and external clients and lead meetings in a technical capacity.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigation, OOS and OOT, as required.
• Mentor others and provide technical direction. Provide leadership for cGMP compliance and technical training.
• Serve as a role model for positive leadership.
• Meet individual and departmental goals as required.
• Apply required cGMP regulations and internal QA procedures.
• Adhere to established laboratory safety procedures.

Additional Responsibilities

• Lead executive and technical parts of projects/ programs related to the implementation of new technologies.
• Guiding or technically supporting customer audits in the testing laboratory area.
• Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues.

Education

• Bachelor's Degree in technical discipline or engineering discipline required or
• Master's Degree in technical discipline or engineering discipline preferred

Work Experience

• Minimum 5 years of experience required and
• Experience in leading and developing others preferred
• Experience in conducting root cause investigations of field units preferred and
• Experience in laboratory test equipment operation and maintenance such as but not limited to Instron, multi-meter, Zwick, CAD, and microscope preferred

Preferred Knowledge, Skills and Abilities

• Prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables.
• Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal)
• Ability to collaborate with and effectively work as part of a global team.
• Active contribution to the progress of global projects and motivation to achieve deliverables in time
• Proficient use of MS Office applications and (desirable Minitab, SAP and Master Control)
• Basic knowledge in Project Management in order to effectively collaborate with the global project management organization
• Self-reliant, diligent, flexible (with working time to fulfill requirements of a global role)
• Clear communication (fluent in written and verbal English required)
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times