Engineer, QA Validation

This hybrid temporary position supports QA oversight of equipment, facilities, and utilities qualification, focusing on data integrity in biologics. The role spans all manufacturing equipment/processes, process automation systems, and analytical equipment. Collaboration with manufacturing, engineering, and QC is essential, guiding project planning and continuous process improvements in manufacturing and lab environments. Success in this role involves supporting partners in identifying and implementing risk-appropriate qualification strategies.

Review and approve user requirement specifications, automation functional requirement specifications, and software design documentation for automated facility, utility, and equipment.

Review and approve FATs, SATs, Commissioning and Automation Acceptance Testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports, and final report packages.

Experience with data integrity implementation in a GMP environment.

Define and document the data lifecycle for GMP systems.

Perform Data Integrity Risk Assessment and develop mitigation strategies.

Implement technical and procedural controls for data accuracy, consistency, and reliability.

Ensure compliance with regulatory requirements and company policies related to data integrity.

Support internal and external audits by providing documentation and evidence of data integrity controls and practices.

Continuously monitor and improve data integrity processes for enhanced efficiency and compliance.

Review and approve Instrument Criticality Assessments, Calibration Quality Events, and Deviations.

Create SOPs/Guideline documents for FUE and automation qualifications for new and existing process changes.

Represent QA Validation in multi-departmental meetings and project teams.

Coordinate qualification and validation activities involving cross-functional, multidepartment teams.

Perform other duties as assigned. Qualifications

5 years of experience in a GMP regulated environment (Biotech or equivalent) with proficiency in engineering.

Experience in reviewing and approving Validation and Qualification lifecycle documentation.

Proficiency in data management systems, software validation, and regulatory compliance.

Ability to comprehend technical information related to equipment, processes, and regulatory expectations.

Experience with regulatory inspections and audits is preferred but not required.

Proficiency with MS Word, MS Excel, MS Project, MS Visio, and MS PowerPoint.

Understanding of FDA & European regulatory requirements and guidelines for validation expectations.

Proficiency in technical documentation writing is required.

Experience in cleaning and sterilization validation protocols is preferred but not required.