HEMA Biologics · 6 hours ago
Quality Validation Engineer
Philadelphia, PA, US
Full-time
Onsite
Senior Level
$108K/yr - $132K/yr
5+ years expHEMA Biologics is seeking an experienced Quality Validation Engineer to focus on the implementation and validation of equipment, utilities, and systems for the manufacture of clinical and commercial GMP pharmaceutical products. The role involves providing Quality oversight and ensuring validation activities are consistent with regulations and company practices.
BiopharmaBiotechnology
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
Qualification
Required
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
Preferred
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
Company
HEMA Biologics
HEMA Biologics is a privately-held biopharmaceutical company focused on patients living with the rarest bleeding disorders.
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-03-12
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