Scientific Search

Validation Manager

Scientific Search Berlin, NY
Scientific Search

Validation Manager

Scientific Search Berlin, NY
3 weeks ago 40 applicants

See who Scientific Search has hired for this role

Onsite in New Berlin, NY

Company Summary: Our client is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world.

What You Can Expect To Be Doing

  • Provide guidance and direction to the Validation Team on all aspects of Validation including Mfg and Pkg Process Validation, production Equipment Qualification, Utility and Lab Instrumentation Qualification, Computer System Validation, and Cleaning Validation.
  • Provide oversight to all critical Validation systems and Compile and analyze data, provide backup preparation of protocols, reports, and make recommendations for changes/or improvements.
  • Report directly to the Sr. Director of Operations & Pharmaceutical Technologies. The Validation Team (Engineers & Cleaning Validation Manager) will report to the Validation Manager.
  • Leadership
    • Ensure proper validation support
    • Define areas of improvement
    • Deliver strategic improvements to current systems
    • Provide insight for capital expenditures to maintain quality/validation systems if needed
    • Provide guidance and oversite to the Validation staff including establishment of Goals and Objectives, schedule and work priorities, performance review, and coaching.
  • Provide oversight to Primary Validation responsibilities such as:
    • Equipment and Instrumentation Qualification Risk Assessment Program
    • Facility and Utility Qualification Program
    • Equipment Periodic Reviews, APR support, and CPV programs
    • Manufacturing Process Validation Program
    • Packaging Process Validation Program
    • Computer System Validation Program
    • Cleaning Validation Program
    • Validation document filing and storage system
    • Validation Change Control input and committee membership
  • General Duties
    • Facilitate and/or support validation training
    • Manage system improvements and projects as required
    • Input to Data Integrity program
    • Member of the Change Management Core Team
    • Participate in Risk Assessments and troubleshooting providing Validation guidance and advic
    • Support audits representing the Validation Team including internal, consultant, and regulatory authority audits.
    • Provide support to the team as a backup resource as needed on all key Validation responsibilities and systems.
What You Will Bring To The Table

  • Bachelor’s degree in a scientific or engineering discipline.
  • Minimum of 5 years in pharmaceutical industry (Process Development, Technology Transfer, Operations, Quality Assurance). Previous work experience should include exposure to a broad range of Pharmaceutical Validation activities such as document control, information technology, production record review, GMP Compliance, Computerize System Supplier Assessment, validation, change control, etc.
  • Experience in leading and/or managing validation activities a must.
  • Prior experience in Managing/Leading People/Groups
  • Strong knowledge in GMP and regulatory requirements

Please email Laura@ScientificSearch.com to learn more about this fantastic opportunity!

#IND1

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Staffing and Recruiting

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