Job Description
One of our large biopharmaceutical clients is seeking a Validation Engineer to join their Quality Assurance team.
Key Responsibilities:
Ensure validation life-cycle activities are performed in compliance with relevant GSK policies and procedures.
Collaborate with direct GSK staff and third-party personnel engaged in drafting validation documents, execution of validation studies, completion of reports / validation life-cycle deliverables, commissioning (where applicable) and start-up, and routine validation during the system/equipment lifecycle.
Create and update validation project plans and timelines.
Subject Matter Expert (SME) representative for quality management document impacting validation, sterilization, cleaning or sterile operations within R&D.
Oversee and manage all validation activities including change management, ensuring all activities are performed following application GMP and GSK procedures.
Support quality investigations, ensure appropriate CAPA are developed and implemented as agreed.
Support internal and external audits and ensure follow-up audit actions are completed as agreed.
Coordinate routine validation activities with owner, maintenance and engineering.
Develop, maintain and optimize validation processes using Lean Sigma / continuous improvement methodologies.
Represent Sterile Clinical Manufacturing team on global technical focus and communities of practice.
Lease with the global pilot plant network for knowledge sharing and best practice regarding sterile assurance.
Manage, write, review and approve validation life cycle SOPs and other technical documents for process equipment, facilities, and manufacturing processes, as required.
Assist the technical transfer process to commercial or CMO sites, as required.
Provide technical support for the implementation of novel manufacturing technologies.
Provide leadership and oversight for site validation programs and initiatives.
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Required Skills & Experience
Bachelor’s degree in Mechanical, Electrical or Chemical Engineering, or BS/BA in a related scientific discipline (e.g. Chemistry, Biology).
5+ years of relevant technical experience in a validation capacity working in a GMP biopharmaceutical or sterile manufacturing environment (clinical or commercial).
Nice to Have Skills & Experience
Experience with any of the following: Isolator, Lyophilized, External Vial Washer, autoclaves, aseptic filling desired.
Ability to work in a complex, multi tasking environment across local and functional teams.
Ability to organize and effectively lead multiple diverse, cross-functional teams.
Comprehensive knowledge of pharmaceutical systems qualification requirements and quality compliance. (GMP,ICH, FDA, US, EP, JP, etc.).
Basic knowledge of aseptic techniques and sterility assurance requirements related to aseptic processing / terminal sterilization and validation of manufacturing equipment use for aseptic manufacturing.
Basic knowledge of microbiology as it relates to cleanroom environments and aseptic processing / sterile manufacturing.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.