Process Engineer

Job Title: Process Engineer

Location: Irvine, CA (on-site)

Required Experience:

medical device industry experience in design control and/or project engineering, 10+ years of experience & demonstrated proficiency in Process engineering & providing ongoing technical support is preferred with evidence of continued self-development.

Must Have Technical/Functional Skills

Knowledge about GxP

Strong creative, analytical and problem-solving skills.

Proficient at interpreting data and putting that data into a report.

Experience in writing software specification documents

Process experience, ability to observe and understand manufacturing processes.

Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.

Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software

Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

Good experience in Validation (IQ, OQ & PQ).

Ability to read engineering drawings, GD&T, terminology, schematics.

In-depth knowledge of design of medical devices preferred.

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are:

Programming, Setup, Update MOP

Exceptional in validations, Executing DOEs and characterizations that build to robust validation Work in a cross-functional team environment

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.