Job Title

Senior Specialist, Validation Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Senior Specialist, Validation to join our team! What We Offer A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive health, dental and disability insurance programs, a group retirement plan and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland (Quebec) and Spokane (Washington). As a fully integrated contract manufacturing organization, Jubilant HollisterStier is equipped to manufacture sterile injectable formulations, as well as solid and semisolid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier is proudly part of the Jubilant Pharma family. For more information, visit www.jublhs.com . Purpose of the Job Responsible for development and execution of qualification protocols for equipment, computerized system, utilities, manufacturing operations and cleaning. Technical support for operations and service departments. In charge of complete validation projects. Responsibilities Responsible for the validation projects and related followups. Responsible for sterilization cycle development and preparation and execution of sterilization validation protocol and reports. Responsible for execution of the VMP for sterilizers, depyrogenation and SIPs. Work with project engineering personnel, process development, regulatory and QA to ensure requirements related to sterile processing activities are appropriately considered and addressed in design and technology agreements and commitments. Prepares and executes qualification protocols and reports for equipment, computerized system, laboratory instruments and utilities. Review, analysis and evaluation of qualification test results, determining acceptance and ensuring that test exceptions and protocol discrepancies are properly documented and justified. Reviewing and approving IQ, OQ, PQ and PV protocols and change control documents. Responsible for the execution of the annual requalification program. Ensures that protocols and reports comply with established corporate standards and cGMP regulations. Ensuring that project deliverables meet internal procedures and client requirements. Provides validation support during the design, installation, startup and production for new and existing equipment and systems. Assist in sterilization depyrogenation process. Perform requalification and reevaluation activities. Assist in new product introduction regarding packaging process validation and equipment / utilities / computer system qualification. Support capital engineering project regarding validation activities. Support the Cleaning Validation Program. Performs additional duties as assigned by management. Education & Experience Bachelor degree in Engineering or Science. Minimum 10 years of experience in pharmaceutical manufacturing validation. Minimum 5 years of experience in Cleaning Validation Program. Must have handson experience in writing qualification documents and engineering studies. Skills Required Strong skills to take in charge of complete validation projects. Knowledge and skills related to technical tasks. Proficient in use of Microsoft Office software applications. Strong technical knowledge of FDA, EMEA, ISO and Canadian GMP. Ability to effectively communicate and write required documents in French and English. Strong interpersonal skills and ability to work effectively within a team. Flexibility to work extended hours and during weekends as needed to achieve results. Skills in mentoring junior staff. Quality and detail oriented. Analytical problem solving. EEO & Disability Statement Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. We foster an inclusive environment where our employees can thrive and where differences are welcomed. If qualified individuals with a disability need assistance in applying for this position, contact Human Resources at [email protected] informing us regarding the nature of your request and providing your contact information. #J-18808-Ljbffr