Quality Validation Engineer

About This Role

Implement and validate equipment, utilities, and systems for GMP pharmaceutical/biological product manufacturing, ensuring compliance with regulations and internal practices. Provide Quality oversight on changes to products, processes, equipment, software, and facilities.

Responsibilities

• Develop and author validation master plans with a lifecycle approach for installation and qualification of equipment, utilities, and GMP systems in cell therapy manufacturing facility.
• Define Validation/Qualification deliverables including requirements, functional/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, identifying and resolving deviations and technical issues.
• Understand metrology/instrument calibration program requirements to support validation tasks.
• Coordinate qualification projects with other departments (QA, Manufacturing, Process Development, QC).
• Apply quality risk management principles using various risk assessment tools.
• Identify opportunities for and implement continuous improvement and optimization of validation practices.
• Ensure work is performed in accordance with applicable regulations, cGMPs, industry guidelines, and company policies and procedures.
• Support on-going qualification and validation related issues and deviations and technical transfer projects.
• Perform change control assessments and review/approve change control implementation plans.
• Maintain inspection readiness and actively support regulatory inspections, internal or external audits.
• Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Validation SME.

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
• 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
• 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 (e.g., FMEA)
• Ability to work well on cross-functional teams and independently
• Strong organizational skills and ability to prioritize multiple tasks
• 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
• Proficiency in Microsoft Word, Excel, PowerPoint

Qualifications

• Bachelor’s Degree in Science or related technical field
• Minimum of 5 years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.

Nice to Have

• Experience with Calibration manager databases
• Experience with Electronic Lab Notebooks
• Experience with Veeva
• Experience with Validation Data Acquisition systems (ie Kaye, Ellab, TempTale)
• Experience with Building Management systems
• Experience with 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
• Experience working with cell and gene therapies or biologics products
• Experience working with external parties and/or leading cross-functional teams

Skills

* Required skills