Equipment Validation Engineer

Job Description

Equipment Validation Engineer (6-Month Temporary Assignment)

Manufacturing Engineering Camarillo, CA

At PBS Biotech, we are advancing the future of cell therapy manufacturing through innovative single-use bioreactor systems that enable scalable, high-performance processes for life-saving therapies. As a fast-growing biotechnology company, we are committed to delivering cutting-edge solutions that help our partners accelerate development from research to commercialization.

We are seeking a highly motivated Equipment Validation Engineer to join our Manufacturing Engineering team on a 6-month temporary assignment. This role will play a critical part in supporting production readiness by leading and executing equipment validation activities in a GMP-regulated environment.

In this position, you will be responsible for developing and executing validation plans for new and existing manufacturing equipment, partnering cross-functionally with Quality and Engineering teams, and ensuring compliance with regulatory and internal standards. You will also contribute to process improvements, troubleshooting efforts, and the implementation of robust manufacturing procedures to support operational excellence.

This is an excellent opportunity for an engineer with hands-on experience in equipment validation, process development, and GMP environments who is looking to make an immediate impact within a collaborative and innovative manufacturing organization.

Below are the responsibilities for the role.

Primary Responsibilities

Develop validation plans for implementing new equipment or upgrading equipment in accordance with GMP standards.

Partner with the Quality organization is the development of validation plans.

Author validation reports

Create and Manage Change Records for the implementation of new equipment.

Assist manufacturing engineering by trouble shoot malfunctioning equipment, when required.

Implement new or changes to manufacturing procedures in support of validation activities.

Lead process improvement efforts for robust manufacturing processes

Develop and qualify fixturing to assist operators in assembling products

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

Knowledge/ Experience

Bachelor's degree in Mechanical Engineering or Industrial Engineering.

Experience with validating manufacturing equipment and processes under GMP guidelines

Process development experience for manual and semi-automated assembly processes

Experience with CAD programs

Experience performing Tolerance Analysis

Minimum of 3 years of experience

Skills/ Abilities Pertinent to This Position

Ability to author validation plans and reports

Ability to troubleshoot equipment and implement improvements

Ability to make minor repairs on equipment

Ability to work with CAD software

Ability to analyze data

Ability to perform tolerance analysis

Ability to author engineering plans and reports

PHYSICAL DEMANDS

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing equipment. Must be able to lift various weights as needed to meet job requirements.

WORK ENVIRONMENT

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

Occasionally exposed to moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant. Personal protective equipment (vision and hearing) used in plant. Exposed to heat, humidity conditions during warm weather months.

Full-time