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 semi-solid 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 .We continue—with the utmost care for the environment and society—to create value for our clients and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you're ready for a rewarding challenge, we invite you to take the first step and apply today!Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We foster an inclusive setting where our employees can thrive and where differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health overall.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 follow-ups.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 the acceptability, 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,



start up and production for new and existing equipment and systems.Perform requalification and re-evaluation activities.Assist in new product introduction in regards to packaging process validation and equipment/utilities/computer system qualification.Support capital engineering project in regards to validation activities.Support the Cleaning Validation Program.Performs additional duties as assigned by management.Education & Experience:Bachelor degree in Engineering or ScienceExperience Required:Minimum 10 years of experience in pharmaceutical manufacturing validation.Minimum 5 years of experience in Cleaning Validation Program.Must have "hands on" experience in writing qualification documents and engineering studies.Skills Required:Strong skills to take in charge 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.Salary ranges from $65,524 to $109,207 depending on education level and years of experience.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.Join us, and be a part of our global success story!#J-18808-Ljbffr

📌 Senior Specialist, Validation - $65,524 - $109,207 A Year (Kirkland)
🏢 Jubilant Hollisterstier
📍 Kirkland