Develops biological and chemical product manufacturing processes that support Operations Departments within the niche diagnostics business. Receives no guidance on repetitive tasks. Receives general instructions and periodic guidance regarding required tasks and expected results.
- Conceptualize, Develop, Verify and Validate engineering solutions for automated control systems that supports plant activities including, scrap reduction, customer complaint corrective action, & productivity improvements.
- Responsible for capital project management from justification to the implementation of automated manufacturing systems from bulk formulations to filing and final product packaging. This includes the development equipment specifications & the ability to work with a wide variety of external suppliers to obtain quotations.
- Develop project plans and capital appropriations requests. Prepares project timeline and ensure project is kept within scope, time and cost. Keep internal customers informed of project status.
- Collaborate, and lead as necessary, multi-disciplinary project teams and contribute hands-on directly to the completion of projects. Recommends and participates in functional training to advance technical capabilities of group
- Proactively contributes to advancement of process capability within Thermo Fisher Scientific groups by assisting in efforts to improve processes (PPI).
- Stays current with all applicable QSR and ISO regulatory requirements as well as industry standards.
- Performs other related duties and assignments as required.
- B.S. Degree in engineering (mechanical, electrical, industrial or design preferred) or related scientific discipline with a minimum of 7-10 years of relevant industry experience
- College and/or technical training in the following disciplines is useful: PLC/HMI programming, design software, microbiology, biological science, chemistry, technical writing, machinery, physics and statistics.
- Project management skills. Mechanical aptitude and experience. Knowledge of microbiology and microbiological testing equipment.
- A strong understanding with mechanical/process drawings and P&ID’s. Knowledgeable in industrial sterilization SIP and CIP systems. GMP and experience working in a regulated industry.
- Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.