Computer System Validation Engineer III

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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 Validation Engineer III - CSV. This position authors, executes, reviews and approves computer systems validation projects as directed by management. Acts as a CSV SME. Validates and qualifies complex computerized systems and software platforms for GxP use. Review's change control for validated systems and may train lower level personnel.

Responsibilities:

• Documentation Preparation (Validation plans, User Requirement Specifications, Functional Specifications, Risk Assessments, Traceability Matrices, Protocol and Report Generation) (50%).
• Protocol Execution (40%).
• Change Control validation assessments for Computerized Systems (5%).
• Training personnel in CSV practices (5%)
• Annual evaluation of GMP Computerized Systems
• Regular and reliable attendance on a full count 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 or Information Technology (IT) discipline or equivalent experience required.
• Minimum of six (6) years of relevant experience in IT, quality, validation, or process engineering.
• GxP hardware and/or software experience required.
• Strong background in IT systems and strong knowledge of cGMP and validation regulations and requirements.
• 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.

The anticipated salary range for candidates who will work in California is $85,439.98 - $119,615.97

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 and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will be asked to complete 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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