Process Validation Engineer

2 weeks ago

South San Francisco, United States a Biopharmaceutical company based out PA Full time

Process Validation Engineer (Contract)


RESPONSIBILITIES

  • Overseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility.
  • Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents.
  • Collaborating with senior leadership to develop long-term strategic plans aligned with operational strategies for process, facility engineering, and controls.
  • Implementing process improvements, including selecting and modifying new equipment and facilities.
  • Writing, reviewing, and editing technical documents, such as Equipment Specifications, Test Protocols, SOPs, CAPAs, and Change Controls.
  • Revising documents as necessary to accurately reflect current procedures.
  • Reviewing and editing documents created by team members for accuracy, clarity, and consistency.
  • Participating in technology transfer, conference calls, and sharing technical information.
  • Adhering to GMP and SOPs, including GDP, and ensuring data recording compliance with regulatory requirements.
  • Ensuring documentation compliance with internal requirements, FDA, EMA, and ISO standards.
  • Attending weekly management meetings to discuss timelines and priorities.
  • Managing projects to ensure timely initiation and completion.


QUALIFICATIONS

  • Minimum 2+ years of related BioPharma Life Sciences experience.
  • Experience in process simulation, preparing and checking process deliverables, and participating in design safety reviews and HAZOPs.
  • Desired experience with GMP procedures, including change controls, deviation management, and CAPAs.
  • Extensive knowledge of small-scale cell culture processes and techniques preferred.
  • Cell therapy manufacturing experience is a plus.
  • Experience interfacing with automation, facility design, and mechanical design groups.
  • Experience interfacing with CQV and operations teams.
  • Excellent oral and written communication skills.
  • Strong analytical, presentation, and interpersonal skills.
  • Exceptional attention to detail and follow-through.
  • Effective technical presentation skills.
  • Excellent verbal and written skills in communicating regulatory and technical information.


EDUCATION

  • Bachelor's or Master's degree in Chemical, Mechanical, Biochemical Engineering, or related discipline.

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