Validation Specialist II - San Diego, CA

Employer: Ajinomoto Bio-Pharma Services

Job Description:
Validation Specialist II
Location: San Diego, CA
Department: QA Validation - 760
Validation Specialist, San Diego, CA
Ajinomoto Bio-Pharma

Together, Let’s Make A Difference.

Validation Specialist II wanted for Automated Visual Inspection and Packaging Equipment validations. The Validation Associate II is responsible for performing semi-complex validation and qualification activities for critical equipment, utilities and processes used in cGMP Fill Finish, Biologics Manufacturing, Packaging and Labeling, and Quality Control.

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Performing equipment validations, analysis and reporting of data in summary reports.
The position is responsible for scheduling activities with equipment owners and ensuring routine activities are completed on time.
Assists in the setup and execution of automated visual inspection, autoclave, depyrogenation oven, and steam-in-place sterilization studies. Responsible for performing validation documentation preparation and review for manufacturing process, equipment, and utilities in accordance with relevant guidance documents and current industry best practices.
Executes validation protocols.
Works closely with cross-functional departments as necessary to schedule and perform tasks.

Skills needed to be successful in this role:
Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent experience.
Minimum of two (2) years of relevant metrology, validation, or process engineering experience.
Minimum one (1) year of cGMP experience.
Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Proficient in Microsoft Word and Excel.
Experience with Kaye Validator preferred.

We provide a Total Rewards package designed to make life better – both at work and at home.
Annual Bonus Opportunities for All Employees
15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
Paid Parental Leave
Annual Company Shutdown in December
Comprehensive Medical, Dental + Vision
401K Company Match + Immediate Vesting
Backup Daycare and Eldercare
Monthly Employee Appreciation Events and Food Truck Fridays
Employee Discount Programs
Tuition Reimbursement
Casual Dress Code
Wellness Programs
Community Outreach Opportunities

At Ajinomoto, every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

If you meet the requirements above, and would like to apply for this position, please visit our website at and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Contact Person:
Location: San Diego, CA
Application Method: Online:
Base Pay: DOQ

Posted on December 02, 2021

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