Engineering - Engineer - Process (Mid Level)

05 to 06 months contract, could potentially extend through 2027 if budget is approved
Standard day shift, Mon–Fri, 8 hr/day
 

Top 3 must have skills:
1) Degree in engineering
1) Process Validation(IQ/OQ/PQ), Risk Management(FMEA)
2) 13485 knowledge/experience

Looking for a qualified Engineer capable of leading a cross-functional project team and executing on design technical documentation.

1) Scope of Services
a. Project Management
i. Manage weekly tasks and updates with the project team.
ii. Coordinate on-site teams regarding process validation and equipment installations.
b. Design & Sustainment
i. Author and review DHF artifacts including
1. Process Validation Owner: Installation and Operation Qualifications (IQ/OQ) and Performance Qualification(PQ)
2. Risk Management, pFMEA
3. Design Transfer
ii. Understanding of statistical analysis, Design of Experiments(DOE), and Test Method Validation(TMV)
c. Desired, not required, product technical understanding:
i. Blending;formulations, mixing dynamics, tank design
ii. Filling/packing;liquid dispensing, capping, labeling equipment, packing assembly
iii. Measurement systems;UV Spectroscopy, pH, Viscometer, moisture analyzer
d. General
i. Proficient in Microsoft Office
ii. Basic understanding of quality systems, e.G. ISO9001, ISO13485
4) Minimum Qualifications Required
i. Bachelor’s degree in engineering or related degree.
ii. 2+ year’s experience in a regulated industry with design controls requirements