Process Validation Scientist

3 weeks ago

Frederick, United States GForce Life Sciences Full time

Internal Title: Process Validation Scientist

Duration: 11-month contract

Onsite in Frederick, MD


Responsibilities:

Demonstrating Upstream and Downstream Unit Operations Knowledge:

  • Utilize your understanding of bioprocessing principles to optimize cell culture and purification processes.
  • Ensure efficient transfer of processes from lab scale to commercial production, maintaining quality and yield.

Leading Process Validation Activities:

  • Develop and implement robust process validation strategies.
  • Review and approve validation protocols and reports, ensuring compliance with regulatory requirements.
  • Generate timely Chemistry Manufacturing and Controls (CMC) documentation.
  • Collaborate closely with MS&T, Manufacturing Regulatory, and Quality teams to ensure alignment and compliance.
  • Provide statistical support for product monitoring using various techniques like statistical process control, process capability analysis, and regression analysis.
  • Develop strategies for investigating process deviations and their impact on process validation.

Collaboration and Communication:

  • Work closely with the global process validation team to share best practices and ensure consistency.
  • Communicate trends in Continued Process Verification (CPV) to Quality Management and CMC teams.
  • Present and defend process validation packages and strategies during audits and inspections.


Qualifications:

  • Bachelor’s Degree in Science or Engineering (Master’s or PhD preferred).
  • 5-7 years of experience in the pharmaceutical or biotech industry
  • previous process validation experience
  • Comprehensive knowledge of PPQ and CPV regulatory expectations.
  • Strong understanding of upstream and downstream bioprocessing units.
  • Familiarity with CMC activities related to Process Validation/Performance Qualification.
  • Proficiency in statistical tools and techniques used in the Biotech industry.

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