Sr. Process Engineer - Contract

Job Title: Sr. Process Engineer
Location: Richmond, IL 60071
Duration: 05+ Months

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

a. Required

i. bachelor's degree in engineering or related degree.

ii. 2+ years' experience in a regulated industry with design controls requirements

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