Process Validation Engineer (Contract) - a Biopharmaceutical company based out PA

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.

a Biopharmaceutical company based out PA

05/20/2024

Philadelphia,PA