Senior CQV Validation Engineer – Combination Products & Packaging Manufacturing - (JP15567)

About the Role

This position serves as a technical leader responsible for supporting commercial GMP manufacturing operations while driving the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes. This role applies advanced engineering principles to ensure robust, compliant and efficient manufacturing processes that support both commercial production and new product introduction. The engineer provides day-to-day technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and implementation of continuous improvement initiatives to enhance product quality, process capability, and operational excellence. Working cross-functionally with Manufacturing, Quality, Validation, Engineering and other technical organizations, the Senior Engineer leads complex engineering initiatives, resolves technical challenges, and identifies opportunities to improve equipment reliability, process performance, and manufacturing capability. This individual serves as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring compliance with regulatory requirements while supporting the successful commercialization and lifecycle management of the business's product portfolio.

Top Must-Have Skills

• Demonstrated experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment, with direct experience supporting packaging equipment, combination products, and/or device assembly processes.
• Hands-on experience using electronic quality and document management systems, including KNEAT, Veeva, TrackWise, or equivalent platforms for managing validation documentation, change controls, deviations, CAPAs, and quality records.
• Ability and willingness to be onsite and support manufacturing operations during off-shift hours, including weekday and weekend night shifts, as required to execute validation activities, and support commercial manufacturing schedules.

Day-to-Day Responsibilities

• Provide technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter optimization, deviation investigations, and continuous improvement.
• Author and execute engineering studies, characterization, Commissioning, Qualification, and Validation (CQV) protocols, and technical summary reports to support compliant and reliable manufacturing operations.
• Author, execute, and/or approve technical documentation including:
  • Characterization test protocols and reports
  • Commissioning, Qualification, and Validation (CQV) test protocols and reports for manufacturing equipment, computerized systems, and processes
  • Engineering studies and technical assessments
  • Validation Master Plans, Validation Plans, and Summary Reports
  • Technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI)

Basic Qualifications

• Doctorate degree OR
• Masters degree and 2 years of experience OR
• Bachelors degree and 4 years of experience OR
• Associates degree and 8 years of experience OR
• High school diploma / GED and 10 years of experience

Preferred Qualifications

• Demonstrated hands-on experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP biotechnology or pharmaceutical manufacturing environment, including authoring and executing characterization, validation, and engineering test protocols, as well as preparing technical reports to support equipment/system qualification and process validation.
• Ability to work autonomously and demonstrate strong technical ownership of commercial manufacturing support, including equipment and process troubleshooting, critical process parameter optimization, deviation investigations, root cause analysis, and the ability to implement data-driven process improvements in a regulated manufacturing environment.
• Willingness and ability to work onsite to support commercial manufacturing during off-shift operations, including weekday and weekend night work, with the flexibility required to execute validation activities and provide engineering support during critical manufacturing, qualification, and project schedules.