Gestionnaire, Validation / Manager, Validation

Jubilant Pharma, LLC; Montreal; On-site; CAD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Validation Manager to lead the validation efforts within their rapidly growing organization. This role involves directing the design and execution of the site validation master plan, ensuring compliance with regulatory requirements, and managing a talented team of specialists. You will develop validation protocols, coordinate resources, and provide technical expertise during regulatory inspections. Join a company that values growth and professional development, offering a competitive salary and comprehensive benefits. If you are ready for a rewarding challenge in a dynamic environment, this opportunity is perfect for you.

Benefits

Comprehensive medical insurance

Dental insurance

Disability insurance

Retirement savings plan

Health and wellness programs

Qualifications

• Bachelor’s degree in Science/Engineering required.
• Experience in managing large, complex projects is essential.

Responsibilities

• Directs the design and execution of the site validation master plan.
• Develops validation protocols for various equipment and processes.
• Supervises a team of Validation Specialists and manages the department budget.

Skills

GMP regulations knowledge

Validation principles

Strong communication skills

Moist heat sterilization

PLC software understanding

Electrical and mechanical systems knowledge

Project management techniques

Negotiation skills

Education

Bachelor's Degree in Science/Engineering

Tools

Project management software

Job description

Validation Manager

Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting for a Validation Manager to join our team!

What do we offer?

A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a collective retirement savings plan, and health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. A fully integrated contract manufacturing organization, Jubilant HollisterStier has the capability to manufacture sterile injectable preparations, 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 a proud member of the Jubilant Pharma family. For more information, visit www.jublhs.com.

We will continue, with the utmost care for the environment and society, to enhance value for our customers and stakeholders by delivering innovative products and economically effective solutions through growth, profitability, and judicious investment of resources. If you are ready for a rewarding challenge, we invite you to take the first step and apply today!

Position Objective

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.

Key Accountabilities

1. Directs the designing, planning and execution of the site validation master plan.
2. 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.
3. Establishes qualification requirements and acceptance criteria from the review of Engineering P&ID's drawings, functional specifications, turnover packages, results from Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and commissioning and qualification activities.
4. Directs the coordination of resources needed to complete validation tests.
5. Prepares presentations for regulatory agencies regarding the validation program.
6. Provides technical expertise and supports Quality Assurance during regulatory inspections.
7. Develops and leads training programs for the validation department.
8. 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.
9. Ensures compliance of the validation program with the current GMP requirements of the regulatory agencies in the certification program.
10. Ensures compliance of the validation program with the current CCS (Contamination Control Strategy) requirements of the site.
11. Develops, implements and monitors the site validation procedures in compliance with the Life Cycle approach, ensuring continuous compliance with GMP.
12. Coordinates and supervises the activities of validation contractors.
13. Reviews, analyzes 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).
14. Manages the department budget.
15. Supervises a team of Validation Specialists. Responsible for training, performance and evaluations.
16. Performs additional duties as assigned by Management.

Key Interfaces

External

External relationship of different service providers and suppliers.

Internal

Education Qualification:

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

Experience in effectively managing large, complex, cross departmental projects.

Skills Required:

1. In-depth knowledge of GMP regulations and guidance documents of Canadian, U.S. and European regulatory agencies.
2. Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
3. Strong written and verbal communication skills (including technical writing).
4. Strong knowledge and practical experience with moist heat sterilization processes (terminal sterilization) and sterilization by filtration (aseptic processing).
5. Good understanding of PLC software and ladder logic diagrams and flowcharts.
6. Good understanding of electrical and mechanical systems and specifications including HVAC and P&ID’s.
7. Strong management and interpersonal skills.
8. Ability to complete assignments on time and on budget.
9. Knowledge of project management techniques and software.
10. Demonstrated ability to effectively perform in a fast-paced environment, handling multiple projects simultaneously.
11. Flexibility to work extended hours and weekends as needed to achieve results.
12. Proven strong negotiation skills and ability to manage outside contractors effectively.

Physical

No special physical demands are required to perform the work.

1. Work involves everyday risks and does not require any special safety precautions.
2. Involves working in a sterile environment where environmental conditions are controlled and where sterile garments must be worn at all times.