Posting date: April 1, 2014
Become part of a business unit committed to improving the quality of life of transplant patients and their families. Our business is committed to developing and producing innovative quality medical devices for the clinical and research segments of the transplant community.
The Technical Operations team is responsible for process validations, technical transfer and technical support for reagents, test kits and instrument assembly. This team is critical as TDX implements continuous improvement throughout our facilities and processes.
Process Validation Engineers are responsible for writing, executing, and reporting validation protocols and other relevant documentation. These protocols can include but not be limited to User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation and process validation in support of the equipment, products and processes at TDX. The position also requires the use of Risk Assessment tools and the execution of Periodic Reviews where appropriate. Engineers will also have responsibilities in the areas of process engineering and improvement, interfacing with Research & Development and Manufacturing. Team will also interface with Operations, Quality, Operations Excellence and Engineering.
- Coordinate and perform validation projects and protocols in support of equipment, product, process and cleaning validation.
- Write and review protocols and reports.
- Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
- Collaborate with R&D to ensure successful process development and technical transfer to Operations.
- Coordinate validation activities in support of assigned validation projects working closely with Quality Engineering, Engineering, Operations Excellence, etc.
- Recommend approval or failure of validation reports.
- Provide support to Operations to ensure protocols are executed as intended.
- Maintain knowledge and comprehensive understanding of relevant Medical Device / pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation.
- Be a resource to other departments for product and process knowledge.
- Works with Operations Excellence, Operations & Quality to drive efficiency and implement future state processes.
- Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
- Provide technical skills for Kaizen events and other Lean initiatives.
- Promote a collaborative Team environment that fosters creativity, innovation and high performance.
- Completes process validations.
- Performs root cause analysis and suggest workarounds and/or solutions for recurring issues.
- Bachelor’s degree required, with majors in Engineering or Science
- An advanced degree such as an MBA is a plus. Project Management certification (PMP) is a plus.
- Three years relevant experience in medical device or pharmaceutical arena required
- Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation systems.
- Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
- Strong project management and organizational skills.
- Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
- Excellent verbal and written communication skills.
- Previous experience in problem solving methodology.
- Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
- Proficient in use of Microsoft Office Suite.
- Must be able to travel as needed.
- Performs all job duties in a safe manner, consistent with the Code of Ethics and the Thermo Fisher Scientific 4-I core values of Integrity, Intensity, Innovation, and Involvement.
- Performs other duties as assigned.
This position has not been approved for Relocation Assistance.