Equipment Validation Engineer

PBS Biotech, Inc. is a fast-growing private company based in Camarillo, CA that manufactures and sells the most advanced single-use bioreactors for the biopharmaceutical market. We are seeking a highly motivated Equipment Validation Engineer to support validation activities in production.
This is a temporary 6-month assignment that would be eligible for benefits.

Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

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 trouble shoot 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.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Work Location: Camarillo, In person