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

Directs the design, planning and execution of the site validation master plan. Ensures that validation activities are in compliance with regulatory agencies GMP's and guidance documents

Responsibilities:

• Directs the designing, planning and execution of the site validation master plan.

• Develops the validation protocols and validation reports for the plant computerized and non-computerized equipment/systems/utilities and automated systems, sterilization / depyrogenation / drying /fill volume processes, inspection validation processes, packaging validation processes, room qualification process and cleaning validation process.

• Establishes qualification requirements and acceptance criteria from the review of: Engineering P&ID's drawings, functional specifications, turn over packages, results from Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and commissioning and qualification activities.

• Directs the coordination of resources needed to complete validation tests.

• Prepares presentations for regulatory agencies regarding the validation program.

• Provides technical expertise and supports QA during regulatory inspections

• Develops and leads training programs for the validation department.

• Develops, implements and maintains the SOP's for validation department to include the implementation of the validation program and the execution of the qualification tests.

• Ensures compliance of the validation program with the current GMP requirements of the regulatory agencies in the certification program.

• Ensures compliance of the validation program with the current CCS (Contamination Control Strategy)requirements of the site.

• Develops ,implements and monitors the site Validation procedures in compliance with the Life Cycle approach, ensuring continuous compliance with GMP.

• Coordinates and supervises the activities of validation contractors.

• Reviews, analysis and evaluates the qualification test results, determines the acceptability, and ensures that test exceptions and protocol discrepancies are properly documented and justified. Reviews and approves IQ, OQ, PQ, CV and PV documents and any other related documents (eg: change controls, SOP, commissioning documents, risk assessments).

• Manages the department budget.

• Can replace at times any of his direct reports

• Performs additional duties as assigned by Management.

Education & Experience:

Education Qualification:

Minimum education: Bachelor’s Degree, preferably in Science/Engineering

Experience Required:

• 8-10 years of related work experience in sterile pharmaceutical manufacturing.
• Experience in effectively managing large, complex, cross departmental projects.

Skills Required:

• In-depth knowledge of GMP regulations and guidance documents of Canadian, US and European regulatory agencies

• Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agencyexpectationsand industry trends

• Strong written and verbal communication skills (including technical writing

• Strong computer skills

• Strong knowledge and practical experience with moist heat sterilization processes (terminal sterilization) and sterilization by filtration (aseptic processing)

• Good understanding of PLC software and ladder logic diagrams and flowcharts

• Good understanding of electrical and mechanicalblue printsand specifications including HVAC systems and construction plans.

Hiring Wage: $88,000 – $129,000 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role.

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!