Validation Engineer II

Role Summary

Validation Engineer II – You will provide guidance in validation strategy to the site and global projects, with engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. You will assess and validate cleaning processes.

Responsibilities

• Develop protocols, coordinate validation activities, execute, prepare final reports and assemble final validation packages; generate project plans. Conduct initial validation efforts and revalidation. Investigate manufacturing challenges and evaluate/implement process improvements. Archive final documents and support regulatory submissions and audits. Interpret regulatory requirements.
• Collaborate with manufacturing, Engineering, Regulatory, QC, and Quality Operations on a daily basis.
• Apply understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), SOPs, project procedures, and training.
• Manage multiple projects across areas to support manufacturing and engineering; lead and prioritize tasks as needed.
• Review and assess change control requests with potential impact to validated state.
• Engage with project team members to determine validation strategy and system validation requirements, ensuring validation documentation meets regulatory guidelines and industry standards.
• Write protocols and reports; execute, interpret, and evaluate validation documents against GMP, FDA, EU, JP guidelines and applicable regulatory requirements.
• Guide peers in applying quality engineering approaches; use risk analysis tools (FMEA, DOE, QbD, SPC).
• Identify optimization opportunities within the department/site and close compliance gaps as needed.
• Update validation assessments/plans; assist with non-conformances, corrective/preventive actions; contribute to SOP updates as required.
• Participate in internal/external assessments or audits; support closure of observations; assist with regulatory inspections and present validation strategy/protocols.
• Support Global Validation initiatives for harmonization/streamlining.
• Perform other duties as directed by supervisor.

Qualifications

• Required: Bachelor's degree in an engineering discipline; 2+ years of related experience; minimum 2+ years validation experience; experience in manufacturing and cleaning processes; proficiency in pharmaceutical/biotech validation elements and in writing protocols/SOPs; strong cGMP understanding; ability to work independently and in cross-functional teams; leadership skills; strong technical writing/communication/organizational skills; proficiency with Microsoft Office (Word, Excel, PowerPoint, Visio, Project).
• Preferred: Chemical, Mechanical, Electrical Engineering degrees; hands-on Manufacturing/Engineering/Technical Service experience.

Skills

• Quality Engineering, validation lifecycle concepts, project management, and documentation control.
• Regulatory knowledge (GMPs, FDA, EU, JP standards) and qualification/validation techniques.
• Risk analysis (FMEA, DOE, QbD, SPC); statistical thinking; problem solving.
• Effective written and verbal communication across all levels.

Education

• Bachelor's degree in engineering required.

Additional Requirements

• May lift up to 25 lbs; travel up to 5% may be required; may work in manufacturing/controlled environments with gowning and PPE requirements; may work across shifts including weekends and extended hours as needed.