Jubilant HollisterStier , a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Process Engineer 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 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:

The Process Engineer provides knowledge primarily in the area of pharmaceutical process engineering and technical transfer. This position will manage projects and multi-disciplinary project teams with leadership oversight focused primarily on new product introductions as well as process optimization.

The process engineer will also contribute and provide technical direction for complex projects and exhibit strong communication skills with all levels of employees.

Responsibilities:

New Product Introduction:

• Evaluate incoming processes for robustness, efficiency and fit within JHS equipment
• Technical Transfer of new products from both internal and external clients
• Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
• Develop and execute validation studies to test and qualify new and improved manufacturing processes.
• Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes
• Provide necessary reviews for regulatory and client audits and provide responses to audit observations
• Responsible for optimizing gross profit margin and minimizing deviation rate

Process Optimization:

• Lead and coordinate Media Fill (Aseptic Process Simulation - APS) activitiesto ensure compliance with regulatory requirements and internal quality standards. This includes planning, execution, documentation, and analysis of APS runs to validate aseptic manufacturing processes and maintain sterility assurance.
• Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability
• Oversee and assess existing processes and workflows
• Establish and track process metrics to monitor process stability and discover areas for improvement
• Troubleshooting, oversight of events within Manufacturing will require occasional off-shift at-location support.
• Implement effective CAPAs.

Qualification:

• In-depth understanding of cGMPs, including FDA, Health Canada, and European Union GMP Annex 1 requirements, as well as relevant USP chapters. Must be well versed in scientific principles related to cleanroom operations, room classifications, and aseptic processing, particularly as they apply to media fills (APS), sterilization, and lyophilized products.

Level Specific:

• Expected to perform job functions autonomously with leadership oversight provided to increase effectiveness.

Education & Experience:

Education Qualification (Highest):

• Chemical Engineering Degree or equivalent
• CPMP, green belt or equivalent

Experience Required:

• At least 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience.
• Regulatory Aseptic Expertise
• Supervisory or other Leadership Experience
• Project Management
• Statistical Analysis
• Lean Manufacturing Principles

Skills Required:

• Project Management
• Microsoft Office
• Management of cross-functional team
• Communication with Internal/External customers
• Demonstrated ability influence project outcomes without formal authority
• Interacting with inspectors/auditors from regulatory agencies

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 MTL-TalentAquisition@jubl.com informing us regarding the nature of your request and providing your contact information.

Join us, and be a part of our global success story!