Ajinomoto Bio-Pharma Services: Sr. Validation Specialist

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 Sr.

Validation Specialist, who will be responsible for authoring, executing, reviewing and approving validation protocols, as well as studying documentation as directed.

This position determines critical process parameters and test plans to demonstrate equipment/processes are appropriate for their intended use.

The Sr.

Validation Associate I will also perform complex validation activities for critical equipment, utilities, and processes used in cGMP Fill Finish, Biologics Manufacturing and Quality Control.

Responsibilities:Writes and executes installation, operational, and performance qualification protocols for critical production equipment, utilities and processes which may include: HVAC systems, clean compressed air systems, WFI systems, purified water systems, clean steam systems, nitrogen systems, fermenters, purification skids, vial washers, controlled storage units, autoclaves, depyrogenation ovens, SIP processes, lyophilizers and critical production equipment.Writes detailed validation reports and analyzes complex quality data.Uses Kaye Validator and/or data loggers for temperature mapping controlled storage units, SIP processes, autoclave qualifications and depyrogenation qualifications.Responsible for maintaining revalidation schedules and ensuring the facility remains in a validated state.Writes and reviews SOP’s related to qualification activities.Reviews vendor supplied protocols and documentation for accuracy and compliance with internal requirements.Trains junior team members.Assesses the impact of proposed facility, process, and equipment changes for currently validated/qualified systems and equipment.Troubleshoots and rectifies issues that are complex in nature.Requirements:Bachelor’s degree in a Life Sciences discipline or equivalent experience.

Minimum of 6 years of relevant experience without a degree.Minimum 2-5 years of relevant experience in metrology, validation or process engineering with a degree in Engineering or other relevant degree.Minimum of 2 years cGMP experience.Experience with Kaye Validator operation required.

We provide a Total Rewards package designed to make life better – both at work and at home.Annual Bonus Opportunities for All Employees15 Days Starting PTO (Annual Increase) Sick Time Off Volunteer Time OffPaid Parental LeaveAnnual Company Shutdown in DecemberComprehensive Medical, Dental Vision401K Company Match Immediate VestingBackup Daycare and EldercareMonthly Employee Appreciation Events and Food Truck FridaysEmployee Discount ProgramsTuition ReimbursementCasual Dress CodeWellness ProgramsCommunity 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.