In this role, you will be responsible for leading process validation activities within a biotechnology manufacturing environment. You will develop validation strategies, review technical documentation, and collaborate cross-functionally to ensure compliance and continuous improvement in process validation practices.

Start Date: 02/06/2025

Duration: 6 Months 

Key Responsibilities

  • Develop validation strategies for biotech manufacturing processes, focusing on large-scale mammalian cell culture setups
  • Create and review process validation protocols and reports in accordance with company standards and regulatory guidelines
  • Participate in or facilitate cross-functional risk assessments to determine validation scope and activities
  • Evaluate validation data for compliance with acceptance criteria and support investigations into deviations with appropriate corrective actions
  • Collaborate with quality assurance teams to define standards for validation documentation and ensure all documents meet these standards
  • Review or approve validation-related documents such as risk assessments, technical transfer documents, FMEA, and change requests
  • Assess technical change requests and process-related change requests to determine the need for additional validation efforts
  • Coordinate with QA operations for batch release activities, including approval of deviation reports and change requests
  • Lead the preparation, review, and approval of continuous process verification plans, reports, and periodic reviews
  • Support process development teams during process characterization and risk assessments
  • Serve as the technical lead in cross-functional project teams, organizing meetings and ensuring effective collaboration with manufacturing science and quality teams
  • Act as a point of contact for process validation during regulatory inspections and customer audits
  • Provide training and mentorship to junior team members, fostering a culture of continuous improvement

 

Candidate Profile

  • Bachelor’s or Master’s degree in life sciences, engineering, or a related field
  • Extensive experience in process validation within a biotech or pharmaceutical manufacturing setting
  • Strong knowledge of validation principles, regulatory requirements, and GMP practices
  • Proven ability to develop validation strategies, review technical documentation, and lead validation projects
  • Excellent communication and collaboration skills to work effectively across departments
  • Experience with risk assessments, change management, and deviation investigations
  • Ability to lead technical discussions during audits and inspections

  • Self-motivated with a focus on quality, compliance, and continuous improvement

     

    Job ID 41180685