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. Process Validation Engineer to join the team! In this role you will be responsible for managing drug product process validation activities. This position collaborates with product sponsors to develop process validation programs for each drug product in accordance with the applicable guidance documents. These documents include, but are not limited to, validation master plans, risk assessments, PPQ protocols, PPQ reports, and continued process verification plans (CPV).
- Works directly with clients to develop process validation programs suitable for the applicable drug product(s).
- Authors product specific validation master plans for each drug product to describe the process validation (PV) philosophy and approach in demonstrating capabilities related to the manufacturing of drug products.
- Uses risk assessment tools to evaluate the risks and required mitigation plans associated with the validation of each drug product.
- Authors PPQ protocols and summary reports to describe the procedures, methods, acceptance criteria, and sampling plan required to provide evidence that the drug product processes are reproducible, consistently produce product that meet their quality attributes and are in a state of control.
- Responsible for establishing continued CPV plans to outline formal strategies for evaluating product and process data to provide on-going assurance that the drug product manufacturing processes remain in a validated state during commercial manufacturing.
- Writes and reviews Standard Operating Procedures (SOP’s) related to qualification activities.
- Performs validation impact assessments for change controls.
- Works closely with cross-functional departments as necessary to resolve issues.
- Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
- Minimum of six (6) years of relevant experience in validation or process engineering.
- Strong knowledge of industry guidance documents pertaining to process validation (including, but not limited to FDA guidance for process validation and Annex 15).
- 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.
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
- 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.