Process Validation Engineer
3 weeks ago
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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