Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Sr. Validation Associate I who authors, executes, reviews and approves validation protocols and studies 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 also performs 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.

· Works directly with clients to understand and create complex qualifications.

· Reviews vendor supplied protocols and documentation for accuracy and compliance with internal requirements.

· Trains junior team members.

· May be responsible for updating Validation Master Plans annually and ensuring validation methodology complies with current regulatory guidelines and guidance.

· 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.

· Works closely with cross-functional departments as necessary to resolve issues.

· 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 :

· Bachelor’s degree in a Life Sciences discipline or five (5) years equivalent experience.

· Minimum 2-5 years of relevant experience in metrology, validation or process engineering with a degree in Engineering or other relevant degree. Minimum of 5 years of relevant experience without a degree.

· Minimum of 2 years cGMP experience.

· Demonstrated understanding of GMP compliance and regulations.

· Detail oriented and strong written and verbal communication skills.

· Ability to work independently, within prescribed guidelines, or as a team member.

· Experience with Microsoft Office applications.

· Experience with Kaye Validator operation required

The anticipated hourly range for candidates who will work in California is $33.44 - $46.82.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

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.

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