About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: + Leading pay and annual performance bonus for all positions + All employees enjoy generous paid time off including 14 paid holidays + Health Insurance, Dental Insurance, Vision Insurance – effective day one + Guaranteed 8% 401K contribution plus individual company match option + Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position A validation technician’s primary duty is to participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation, assisting validation engineers or performing tasks independently. Relationships Reports to: Supervisor or above Essential Functions + Document activities via protocols and summary report templates + Establish new templates and policies needed + Review facility changes + Provide input on re-validation + Assess risks involved in processing steps and related to equipment + Develop and/or review validation requirements and design deliverables + Partner with contract validation teams to support and monitor efforts + Monitor validation strategies + Ensure policies are followed + Conduct validation studies in accordance with batch records/protocols + Identify exceptions associated with validation protocol execution + Review atypical interventions (Media Fill, only) + Support resolution of production situations involving aseptic processing capabilities (Media Fill only) + Media Fill / APS Team: + Observe Aseptic Process Simulation (APS) (media fill) executions to ensure compliance with the APS program policy and procedures + Review atypical interventions and support resolution of production situations involving aseptic processing capabilities + Other duties as assigned Qualifications + Education/Experience: + High School/GED + Technical Certificate or higher preferred + 5-8 years of relevant experience + 2 years GMP or regulated industry experience, preferred + Must be able to read and understand English-written job instructions and safety requirements + Technical Requirements: + Ability to use Excel, Word, and other office systems + Ability to learn and use quality management software such as TrackWise® or ComplianceWire® + Ability to understand and independently apply CGMPs to everyday work + Demonstrates understanding of the work tasks assigned + Executes procedures of moderate complexity with high quality + Intermediate understanding of pharmaceutical laboratory and/or production operations + Capable of learning unfamiliar principles or techniques with training + Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor + Ability to problem solve and execute and monitor corrective actions + Ability to interpret data and analyze trends to provide insight into potential issues + Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor + Seeks best practices for daily work activities + Behavioral Requirements: + Ability to see and hear and read and write clear English + Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner + Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time + Ability to cooperate with coworkers within an organized team environment or work alone + Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines + Ability to put aside personal opinions and focus on business needs, department needs or group needs + Ability to transfer knowledge to others via training or mentoring + Demonstrated ability to guide others thorough communication and learning + Ability to make decisions which have moderate impact on immediate work unit Physical Requirements Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.