Process Validation Engineer at Cook Inc. in Bloomington, Indiana

Job Description:

Process Validation Engineer

Posting Date 1 month ago (4/8/2021 6:08 AM)

Requisition ID 2021-8740 Job Location(s) Bloomington IN United States Shift Type First Position Type Full Time Company Cook Inc. Category Engineering

Overview

The Validation Engineer performs and documents validations of medical device manufacturing processes.

Responsibilities

- Validate and implement medical device manufacturing processes as assigned.
- Identify equipment/fixture installation qualification requirements.
- Characterization of processes and their outputs/acceptance criteria.
- Written preparation of applicable validation reports that meet regulatory/company standards.
- Verification testing
- Project management
- Maintain accurate and timely reports and records
- Must have excellent analytical and problem solving skills
- Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.

Qualifications

- Bachelors Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field; or experience of such kind and amount as to provide a comparable background.
- Minimum 3 years experience in medical device process development or process validation.
- Proficient in MS Office applications, especially Excel and Word.

Physical Requirements:

- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.

- Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.