QA Validation Specialist

Location: Kirkland

Jubilant Hollister Stier , a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a  QA Validation Specialist  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 Hollister Stier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant Hollister Stier 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 Hollister Stier is proudly part of the Jubilant Pharma family. For more information, visit
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 environment 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 overseeing the overall compliance of engineering, maintenance, and validation operations with internal requirements, industry best practices, and government and regulatory requirements. Identify gaps, recommend and implement changes to increase the level of compliance of site operations and facilities from an engineering, maintenance, and validation perspective.
Provide support to metrology, engineering, and maintenance through day-to-day assistance and project support. Oversight includes evaluating and reviewing ongoing (corrective) maintenance activities related to equipment and facilities.
Responsibilities:
Assess site compliance with technical programs (e.g., HVAC system design for the sterile area, introduction of new equipment for the aseptic production department, etc.), identify gaps, and act as a subject matter expert to resolve these gaps.
Follow up on open investigations and pending CAPAs for the Maintenance, Engineering, and Validation departments and follow up with each person responsible (e.g., supervisor and/or manager or designated person) on open items.
When equipment issues arise, work with Production, Laboratory, Engineering, Maintenance, and Validation to ensure that all preliminary documentation is prepared appropriately.
Monitor and provide technical guidance for new and ongoing validation of processes and equipment to ensure compliance with internal policies and procedures, GMP, and applicable regulatory requirements.
Oversee the quality of maintenance activities, including corrective work orders and the definition of test criteria for equipment recommissioning and equivalence forms.
Conduct an assessment of the impact of shutdown activities.
Review and approve protocols and reports related to re-qualifications, equipment and facility changes.
Participate in the purchase of new equipment/materials, room layout changes, and facility shutdown activities to assess the environmental/microbiological impact on the sterile production department.
Supervise airflow visualization studies.
Perform other duties as assigned by the Assistant Director of Quality and Compliance and senior management.

Education & Experience:

Bachelor's degree in engineering or science, or any equivalent combination of training and experience.
Experience

Required:

Two (2) to three (3) years of experience in quality assurance/quality control, in a manufacturing environment within the pharmaceutical or healthcare industry and in the regulatory field.

Skills Required:

Good knowledge of pharmaceutical processing techniques.
Good knowledge and understanding of validation, manufacturing, packaging, and testing processes in the pharmaceutical industry.
Excellent knowledge of cGMP regulations for Canada, the United States, and Europe.
Computer skills (Microsoft Office and SAP environment).
Bilingual (French and English). Fluency in English is essential.
Salary ranges from $59,031 to $98,384 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  informing us regarding the nature of your request and providing your contact information.
Join us, and be a part of our global success story!

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