Process Engineer I

2 weeks ago

Carlsbad, United States Eastridge Full time $35 - $40
Job DescriptionJob Description

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities.Eastridge is seeking a Process Engineer I for a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. For immediate consideration, apply today.

Responsibilities:

- Perform wet chemistry formulations and support process characterization of the reagent

formulation processes.

- Support process improvement modification and implementation.

- Support and perform preliminary studies, Guard Band studies, Differential Error Analysis (DEA),

process development Qualification and Validation activities. Analyze and summarize data.

- Support process characterization documentation development and new process implementation.

- Onboarding and qualification of new Equipment for process characterization.

- Perform new equipment Gage R&R, method development, IOQ.

- Draft and/or modify equipment supporting documentation such as EAN, ES, EI, PM, VLP, VLR, MWI.

- Support characterization of wet chemistry processes and scale up manufacturing

- Support creation of Process Flow Diagrams, pFMEA, P-diagram, flow charts, supporting

documentation such as MWI and MF.

- Support CQA Assessment- Identify CQAs from CTQs; Determine Criticality of each CQA to VOC;

Process Impact Analysis and risk assessment for each CQA; Identify Critical Process Parameters

(CPPs).

- Support and/or develop methods to measure performance of process.

- Perform Measurement System Analysis (MSA)/ R&R to understand and address measurement

system sources of variability

- Perform Design of Experiments (DOE) to identify, optimize and control critical process parameter

settings.

- Develop test plans, protocols, and technical reports to ensure designs meet product and part

specifications, and applicable standards for processes including IQ/OQ/PQ protocols and reports.

- Performs process qualification & validation by utilizing IQ/OQ/PQ methodology.

- Perform statistically robust and industry standard analysis of data, and present findings to technical

teams.

- Complete detailed process maps and identify key process input, key process outputs and control

factors for each step.

Requirements:

- Typically requires a B.S. in Chemical Engineering, Bioengineering, or equivalent. Chemistry degree with direct process engineering related experience will be considered.

- 1+ years related process Engineering experience is preferred

- Familiarity with Gap Analysis, Risk Assessment and Change Control Management.

- Familiar with cGMP regulations.

_

Benefits: Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees.From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment.Information about those benefits will be communicated when applicable.


Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.


Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

#IPROPLUS

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