Engineer, QA Validation

This is a temporary position supporting QA oversight of equipment, facilities, utilities qualification, and the associated systems lifecycle management activities for biologics with extensive focus on data integrity. This role offers a diverse breadth of accountability spanning all manufacturing equipment/processes, the embedded process automation systems, and analytical equipment. This individual will work closely with manufacturing, engineering and QC, guiding the plan and design phase of projects and continuous process improvements in the manufacturing plant and lab environments. Supporting partners in identifying and navigating risk-appropriate qualification strategies will be critical to success in this role.

The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• Review and approve user requirement specifications, automation functional requirement specifications and software design documentation for automated facility, utility and equipment.
• Review and approve FAT’s, SAT’s, Commissioning and Automation Acceptance Testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports and final report packages of Facilities, Utilities and Equipment to support implementation of new systems, changes, revalidation and periodic review of existing systems.
• Experience with implementation of data integrity in a GMP environment.
• Define and document the data life cycle for GMP systems.
• Perform Data Integrity Risk Assessment and develop mitigation strategies to address risks.
• Implement technical and procedural controls to ensure data accuracy, consistency, and reliability.
• Ensure compliance with regulatory requirements and company policies related to data integrity, including FDA, EMA, and other relevant guidelines.
• Support internal and external audits by providing documentation and evidence of data integrity controls and practices.
• Continuously monitor and improve data integrity processes to enhance efficiency and compliance.
• Additional responsibilities include reviewing and approving Instrument Criticality Assessments, Calibration Quality Events and Deviations.
• Create SOPs/Guideline documents for implementation of FUE and automation qualifications for both new and existing process changes.
• Represent QA Validation in multi-departmental meetings & project teams.
• Assist with coordination of qualification and validation activities involving cross-functional, multidepartment teams including Manufacturing, Engineering, Process Sciences, Process Development, Quality Control, Quality Assurance, and others.
• Other duties as assigned

Requirements:

• BS in a technical discipline (Engineering, physical or biological sciences). Equivalent experience may be considered.
• Training in project management is preferred.
• 5+ years’ experience in a GMP regulated environment (Biotech or equivalent), with
  exhibited knowledge or proficiency in engineering.
• Experience in the review and approval of Validation and Qualification lifecycle documentation such as URS, IQ/OQ/PQ, Commissioning and Automation testing documentation.
• Proficiency in data management systems, software validation, data integrity principles and regulatory compliance.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Experience with participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred, but not
  Required.
• Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Visio, MS Power Point.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus).
• Proficiency in technical documentation writing required.
• Experience in the review and approval of cleaning and sterilization validation protocols, reports and validation discrepancies is preferred but not required.