Lead CQV Engineer

Responsibilities

Responsibilities for this role include but are not limited to

• Responsible for the creation of qualification and validation programs (Equipment, Utilities, Facilities and Automated systems and computer systems and Software Applications) for the manufacturing site, Quality Control, R&D and Facility support systems.  
• Develop a comprehensive understanding of the manufacturing processes followed for CSL products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps
• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.
• Supports, train and provide guidance to validation specialists/engineers in the delivery of services and areas of expertise.
• Provide technical assistance in terms of Computer System Validation projects and performing the risk assessments and vendor assessments as required. 
• Prepares validation project plans, protocols, and test equipment for execution. Collects and evaluate validation test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies.
• Serve as Subject Matter Expert (SME) for review of Validation and Engineering Qualification documents in adherence to cGMPs, good documentation practices, and general quality oversight.
• Supports the facility as needed in internal and external inspections.
• Followed Computer System Validation Master plan to author, review and approve CSV deliverables for systems as per GxP, GCP, GMP, GDP, cGMP FDA Assessment.
• Use skills including: MS Word, TrackWise, Lab Ware LIMS, STARLIMS, Kneat, doc Net, QMS, PLM, CSV, MESv2, MESv3.1.7.  

Qualifications

• Master of Science degree in Information Systems and Security, or Validation Engineering.  
•  Two years experience in working on projects to develop and execute Equipment, Process, and Computer System Validation documents within the Biopharmaceutical manufacturing facilities;  Two years experience in analyzing deliverables throughout the system development life cycle, including Validation Plan, Design Specifications, Traceability Matrix, and Final Summary Reports for various bioprocess systems; Two years experience in regulatory compliance per FDA 21 CFR part 11, part 210, part 211, part 820, ISO 9001, ISO 13485, ISO 14001, ISO 22716, GAMP 5, CPSC. 
• Regulations and guidelines such as FDA, 21 CFR Part 11, 21 CFR Part 210/211, and ISPE GAMP5; Knowledge of applicable regulations and standards associated with computer systems validation.