As a Sr. Engineer the incumbent independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations manufacturing pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications experiments process and/or capital projects. Develops organizes analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation.
Validation expertise: Experience in drafting executing and approving validation.
Time pressure filling: Hands-on experience with time pressure filling systems.
Technical documentation: Experience in preparing reviewing and approving protocols reports and strategy presentations.
Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes.
Communication skills: Strong written and verbal communication in English and Spanish.
Collaboration: Proven experience working with QA Manufacturing and Engineering teams during critical activities.
Shift flexibility: Willing and able to support non-standard shifts including nights weekends and extended hours.
Requirements
Education in Chemical or Mechanical Engineering:
Doctorate or
Masters 2 years of Engineering experience or
Bachelors in Engineering 4 years of Engineering experience.