Responsable Validation

JOB DESCRIPTION

ENGLISH version below

Responsable, Validation

Qualifications :

Rejoignez-nous :

ENGLISH

Join our dynamic team at Jubilant Radiopharma as Validation Lead We are seeking a driven individual who thrives in a fast‑paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations.

Why Jubilant Radiopharma?

At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high‑quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized.

Role Overview:

The Validation Lead is responsible for the development and execution of qualification protocols for equipment, HVAC systems, computerized system, utilities, cleaning process as well as manufacturing operations. Technical support for operations and service departments.

Key Responsibilities:

- Responsible for annual performance qualification on sterilization and depyrogenation equipment (validation protocol, reports and execution);

- Work with project engineering personnel, process development, regulatory and QA to ensure requirements related to operations activities;

- Prepares and executes qualification protocols, change control test functions and reports for equipment, laboratory instruments, systems, computerized system, and utilities;

- Prepares detailed process validation protocols, including critical parameters, acceptance criteria, and sampling methods for manufacturing processes.

- Assess the impact of changes made to equipment, raw materials, or manufacturing processes on the initial validation, and determine the need for revalidation.

- Prepares cleaning validation protocols aligned with regulatory requirements (e.g., FDA, EMA, Health Canada).

- Conduct risk assessments to justify cleaning limits and identify critical parameters.

- Participates in the execution of the periodic qualification program as per established procedures and timelines;

- Reviews, writes and updates standard operating procedures, working instructions and forms;

- Ensures that protocols and reports comply with established corporate standards and cGMP regulations;

- Manages qualification projects to agree with project plans, timelines and Validation Master Plan;

- Ensures that project deliverables meet internal procedures and client requirements;

- Provides validation support during the design, installation, start up and production for new and existing equipment, systems and utilities;

- Participates in equipment design, evaluation and procurement;

- Supports new product introduction in regards to the manufacturing process;

- Supports investigation and CAPA in regards to the manufacturing process;

- Assists the change control impact assessments;

- Performs additional duties as assigned by Management;

- Flexibility to work during weekends as needed to achieve results.

Qualifications:

- Bachelor's degree in engineering or science

- PMP certification, an asset

- Minimum of 3 years of experience in pharmaceutical manufacturing

- Must have hands‑on experience in drafting qualification documents and engineering studies

- Bilingual in French and English (Supports process and equipment validation, including for production outside Quebec)

Join Us:

If you are looking for a challenging yet rewarding opportunity to make a difference in the healthcare industry, we invite you to apply for the Validation Lead position at Jubilant Radiopharma. Join us in our mission to deliver innovative solutions that enhance patient care and improve lives. Apply now and be part of our success story

#J-18808-Ljbffr