Validation Associate III at Ajinomoto Bio-Pharma Services

Posted in Manufacturing 4 days ago.

Type: Full-Time
Location: San Diego, California





Job Description:

Together, Let’s Make A Difference.

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.

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.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking a Validation Associate III who will be responsible for performing semi-complex validation and qualification activities for critical equipment, utilities and processes used in cGMP Fill Finish, Biologics Manufacturing and Quality Control. Typical daily responsibilities include the performance of temperature mapping studies for controlled temperature environments and the 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. 

Responsibilities


  • 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.

  • Writes validation and qualification summary reports.

  • Assists in the setup and execution of autoclave, depyrogenation oven, and steam-in-place sterilization studies. 

  • Works closely with cross-functional departments as necessary to schedule and perform tasks.

  • Regular and reliable attendance on a full time basis (or in accordance with posted schedule).

  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

Requirements:


  • A degree in Engineering strongly preferred. Bachelor’s degree required.

  • Minimum of four (4) 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

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com 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.

See Job Description





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