Gestionnaire, Validation / Manager, Validation

Jubilant Pharma Limited; Montreal; On-site; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Validation Manager to lead the validation efforts within a sterile manufacturing environment. This role involves directing the design and execution of the validation master plan, ensuring compliance with GMP regulations, and developing protocols for both computerized and non-computerized systems. The ideal candidate will have extensive experience in the pharmaceutical sector, strong management skills, and a deep understanding of validation principles. Join a dynamic team dedicated to maintaining the highest standards of quality and compliance in a controlled environment.

Qualifications

• 8-10 years of experience in the pharmaceutical industry, preferably in sterile manufacturing.
• Strong understanding of quality systems and regulatory expectations.

Responsibilities

• Directs the design and execution of the site validation master plan.
• Develops validation protocols for various equipment and processes.
• Manages a team of Validation Specialists and oversees training.

Skills

GMP regulations knowledge

Validation principles understanding

Excellent communication skills

Validation software proficiency

Management skills

Problem-solving skills

Project management ability

Education

Bachelor’s Degree in Science/Engineering

Tools

Validation software

PLC systems

Job description

Join to apply for the Gestionnaire, Validation / Manager, Validation role at Jubilant Pharma Limited

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.

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, turnover 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 Quality Assurance 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, 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).
• Manages the department budget.
• Supervises a team of Validation Specialists. Responsible for training, performance and evaluations.
• Performs additional duties as assigned by Management.

Key Interfaces

External: Service providers and suppliers

Internal: Manufacturing, packaging, maintenance, engineering, PDS, Commercial, quality

Education & Experience:

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

Experience: 8-10 years in the pharmaceutical industry, preferably in sterile manufacturing

Skills:

• Deep knowledge of GMP regulations and guidance from Canadian, U.S. and European authorities
• Thorough understanding of validation principles, manufacturing processes, quality systems, and regulatory expectations
• Excellent communication skills (written and verbal, including technical writing)
• Proficiency with validation software, PLC systems, and related technical knowledge
• Strong management, interpersonal, and problem-solving skills
• Ability to manage multiple projects, meet deadlines, and work flexible hours

Working Environment:

• No special physical demands; sterile environment with controlled conditions and protective garments required