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    Specialist, Validation

    Jubilant Pharma
    3+ years
    Not Disclosed
    Montreal
    10 Jan. 27, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Specialist, Validation
    Location: Kirkland, Quebec, Canada or Spokane, Washington, USA
    Company: Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc.

    Job Description:
    Jubilant HollisterStier, a leading contract pharmaceutical manufacturer, is currently recruiting for a Specialist, Validation to join our dynamic team. As part of our fast-growing company, you will have the opportunity to work in a collaborative environment with a focus on professional growth, development, and innovative manufacturing solutions. We offer a competitive base salary, comprehensive benefits (medical, dental, disability insurance), retirement savings programs, and wellness initiatives.

    Company Overview:
    Jubilant HollisterStier manufactures sterile injectable formulations as well as solid and semi-solid dosage forms. We operate multiple facilities across North America and India, providing specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. We are proud to be part of the Jubilant Pharma family. For more information, visit www.jublhs.com.

    Position Purpose:
    The Specialist, Validation will be responsible for the development and execution of qualification protocols for equipment, computerized systems, utilities, and manufacturing operations. This position provides technical support to various operational and service departments to ensure that validation activities are carried out in compliance with cGMP standards and regulatory requirements.

    Key Responsibilities:

    • Lead and execute sterilization validation protocols and report generation.
    • Collaborate with project engineering, process development, regulatory affairs, and quality assurance to ensure compliance with requirements related to sterile processing.
    • Prepare and execute qualification protocols, change control tests, and reports for equipment, laboratory instruments, computerized systems, and utilities.
    • Participate in the execution of requalification programs in accordance with established procedures and timelines.
    • Ensure all protocols and reports comply with company standards and cGMP regulations.
    • Manage qualification projects based on agreed-upon project plans, timelines, and the Validation Master Plan.
    • Ensure deliverables meet internal and client requirements.
    • Provide validation support during the design, installation, start-up, and production of new and existing equipment and systems.
    • Participate in the design, evaluation, and procurement of new equipment.
    • Support the introduction of new products by ensuring sterilization processes are validated.
    • Support investigations related to the sterilization process.
    • Conduct decommissioning activities as required.
    • Perform other duties as assigned by management.
    • Communicate effectively with contractors, suppliers, and cross-functional teams.

    Required Education, Experience, and Skills:

    • Education: Bachelor’s degree in Engineering, Science, or a related field.
    • Experience: A minimum of 3 years of experience in pharmaceutical manufacturing, with a focus on validation.
    • Hands-on experience in writing and executing qualification documents and engineering studies.
    • In-depth knowledge of cGMPs and regulatory requirements for equipment and system validation/qualification.
    • Experience working in a sterile environment.
    • Previous participation in remediation plans is a plus.
    • Subject Matter Expert (SME) experience during client and regulatory audits.
    • Proficiency in Microsoft Office software applications.
    • Ability to communicate effectively in French and write cGMP documents in English.
    • Strong organizational skills with the ability to manage multiple projects simultaneously.
    • Ability to review and approve technical validation reports.
    • Strong problem-solving skills, attention to detail, and ability to work under pressure in a dynamic environment.
    • Strong interpersonal skills and the ability to work effectively within a team.
    • Ability to prioritize tasks based on urgency and project needs.

    What We Offer:

    • A culture that values opportunities for professional growth and development.
    • A highly competitive base salary and comprehensive benefits (medical, dental, disability).
    • A group retirement savings program and health and wellness programs.
    • A supportive work environment with opportunities to grow and advance your career in a fast-paced, innovative company.

    If you're ready for a rewarding challenge and want to make a meaningful impact in a dynamic and growing company, we encourage you to apply now!

     

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