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 Drug Product Terminal Sterilization Associate III to join our team! In this role you will be responsible for a variety of product sterilization and biological indicator testing tasks with minimal supervision. This position will also be responsible to authoring and executing standard operating procedures (SOP’s), protocols and batch records in a GMP environment. Responsibilities:Responsible for product transfers between Drug Product manufacturing and Visual Inspection departments.Responsible for Line Clearance and Good Documentation Practices (GDP).Writing and approval of SOPs, protocols, reports and batch records.Responsible for cycle development and design specific to individual product and sterility needs.Designs client / product specific feasibility studies.Run sterilization cycles per established SOP or protocol.Use of validation (validator) and calibration equipment.Loading and unloading of Vials or Syringes onto racks and trays including thermocouple placements.Designs and performs laboratory work for feasibility, D-value and Z-value studies.Orders, specs out, and tests incoming and continued maintenance of biological indicators.Works in conjunction with facilities, validation and engineering with respect to preventive maintenance and work orders.Keep the Terminal Sterilization (TS) calendar up to date by coordination within TS, Manufacturing and Visual InspectionInitiate SOP / BR revisions and Change control (CC), documents.Some client and vendor interaction is expected.Logbook review and completion of applicable batch records.Initiate SOP / BR revisions and CC documents.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 Life Science discipline or equivalent required. Microbiology or Engineering Degree preferred.Minimum of four to five (4-5) years of experience in a laboratory or manufacturing environment.Firm understanding of sterilization sciences / regulations and steam/air utilities.Mechanical aptitude is required.Knowledge of manual inspection techniques and Drug Product manufacturing processes.Detail oriented with strong written and verbal communication skills.Ability to work independently, within prescribed guidelines, or as a team member. 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 OpportunitiesIf 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.