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    Validation Specialist I/Ii/Sr.

    Jubilant Pharma
    0-5 years
    Not Disclosed
    Remote, USA
    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: Validation Specialist I/II/Sr.

    Location: Spokane, WA

    Company: Jubilant HollisterStier LLC, a member of the Jubilant Pharma family

    Job Description:

    Jubilant HollisterStier LLC is seeking a Validation Specialist at various levels (I, II, Sr.) to join our team in Spokane, WA. As a key member of the team, you will be responsible for supporting the installation, upgrade, and validation of critical systems and equipment used in the manufacturing of pharmaceutical products. This role provides an opportunity to work on complex capital, compliance, and contract projects and gain expertise in a regulated pharmaceutical environment.

    Validation Specialist I:

    Responsibilities:

    • Lead and execute equipment requalifications and performance qualifications for critical production equipment.
    • Author equipment requalification reports and assist with change controls and CAPAs.
    • Develop knowledge of equipment such as lyophilizers, terminal sterilizers, autoclaves, HVAC systems, aseptic processing areas, etc.
    • Write and revise SOPs related to equipment requalification.
    • Initiate deviations within the EQMS system and assist with RCA (Root Cause Analysis) and impact assessments.
    • Participate in validation projects, supporting protocol and report generation.
    • Gain knowledge of validation principles and ensure regulatory compliance.

    Validation Specialist II:

    Responsibilities:

    • Lead and execute equipment requalifications, performance qualifications, and other validation work.
    • Mentor less experienced validation associates and specialists.
    • Develop a comprehensive understanding of critical equipment (similar to Validation Specialist I) and systems.
    • Write and revise SOPs for requalification and ensure updated processes.
    • Initiate deviations and change controls, assist with RCA and impact assessments.
    • Lead and contribute to the generation of validation protocols and reports.
    • Ensure compliance with validation principles and regulatory standards in all projects.

    Senior Validation Specialist:

    Responsibilities:

    • Lead complex validation projects and execute equipment requalifications and performance qualifications.
    • Serve as the department approver for SOPs, deviations, change controls, and CAPAs.
    • Develop expert knowledge of validation principles and regulatory standards.
    • Lead the creation of validation strategies for complex projects.
    • Mentor and guide less experienced team members, while managing multiple validation projects.
    • Demonstrate leadership in ensuring compliance with validation practices and regulatory standards.

    Qualifications:

    Validation Specialist I:

    • BS in a hard science (e.g., Biology, Chemistry).
    • Preferably experience in the pharmaceutical or FDA-regulated industry.
    • Strong technical writing, organizational skills, and proficiency in standard business applications (e.g., Microsoft Office).
    • Ability to work in a highly regulated environment with effective communication skills.

    Validation Specialist II:

    • BS in a hard science (e.g., Biology, Chemistry).
    • Minimum of 2 years of validation experience in a pharmaceutical or FDA-regulated industry.
    • Strong technical writing, organizational skills, and proficiency in EQMS, LMS, EDMS, and Microsoft Office.

    Senior Validation Specialist:

    • BS in a hard science (e.g., Biology, Chemistry).
    • Minimum of 5 years of validation experience, including at least 3 years in a regulated industry.
    • Expertise in pharmaceutical validation and FDA regulations.
    • Proficiency in EQMS, LMS, EDMS, and Microsoft Office.

    General Skills:

    • Mechanical aptitude and manual dexterity.
    • Ability to lead and influence outcomes in a collaborative team environment.
    • Strong interpersonal and conflict management skills.

    Compensation:

    • Salary Range: $70,000 – $130,900 (based on experience).
    • Midpoint and above is reserved for employees who demonstrate longevity with Jubilant HollisterStier and exhibit outstanding performance over time.

    Benefits:

    • Medical, Dental, Vision and Flexible Spending and Health Savings Accounts.
    • Life Insurance, AD&D, Short and Long-Term Disability.
    • 401(k) with company match.
    • Generous paid time off and Employee Assistance Program.
    • Optional Benefits:
      • Voluntary Life and AD&D for employee & family.
      • Supplemental Medical Coverage (Critical Illness, Hospital Indemnity, and Accident coverages).
      • Pet Insurance, ID Theft Protection, Perk Spot Discount Program.

    Equal Opportunity Employer:

    Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    For further information on our EEO Policy or to apply, please visit Jubilant Careers.

    If you require assistance applying, contact Human.Resources@jubl.com.

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