Quality Validation Engineer

USWM, LLC • Philadelphia, PA

2d

About The Position

US WorldMeds is seeking an experienced Quality Validation Engineer to primarily focus on the implementation and validation of equipment, utilities, and systems in the USWM -CT production facility for the manufacture of clinical and commercial GMP pharmaceutical/ biological products.

Additionally, this role will provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and USWM’s validation practices and procedures.

Requirements

• Bachelor’s Degree in Science or related technical field.
• Minimum of 5 years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
• Must demonstrate understanding of cGMP’s, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations.
• Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
• Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
• Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA.
• Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks.
• Must possess strong verbal/written communication skills and ability to influence at all levels.
• Experience utilizing quality systems to support Quality Validation activities (Document management, Training, Deviation management, Change Control management, and CAPA).
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Deep knowledge of facility/clean room design, process, equipment, automation, and validation
• Ability to think strategically and to translate strategy into actions
• Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Ability to provide clear direction to team members in a highly dynamic environment
• Candidate must be proficient in Microsoft Word, Excel, PowerPoint.

Nice To Haves

• Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management systems, Document Control Software
• Experience with leading the start-up, validation, and licensure of manufacturing facilities.
• Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation).
• Experience working with cell and gene therapies or biologics products.
• Experience working with external parties and/or leading cross-functional teams

Responsibilities

• Develop and author validation master plans with a lifecycle approach for the installation and qualification of equipment, utilities, and GMP systems used in the manufacture of cell therapy products within the USWM-CT manufacturing facility.
• Define Validation/Qualification deliverables including, but not limited to, requirements documents, functional and design specifications, qualification protocols (IQ/OQ/PQ), and summary reports.
• Develop and author installation/operational protocols and equipment performance/process validation protocols.
• Manage the execution of Validation/Qualification Protocols, including identification and resolution of deviations and technical issues related to equipment, utilities, automation, and cleaning validation.
• Understand the metrology/instrument calibration program requirements to support validation tasks to effectively communicate with supporting teams to keep the project on schedule.
• Coordinate qualification projects, as needed, with other departments, e.g., quality assurance, manufacturing, process development, quality control, etc.
• Apply quality risk management principles including use of various risk assessment tools.
• Participate in efforts to identify opportunities for and to implement continuous improvement and optimization of practices related to validation.
• Ensure that work is performed in accordance with applicable regulations, cGMPs, industry guidelines and practices, and Adaptimmune policies and procedures.
• Support on-going qualification and validation related issues and deviations and technical transfer projects at contractor manufacturing operations for USWM-CT products
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.
• Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.
• Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Validation SME when needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level