Job Title: Senior Validation Process Development Engineer
Location: New Albany, Ohio (On-Site)
Job Summary: We are seeking a Senior Validation Process Development Engineer to support commercial GMP manufacturing operations and drive the development, characterization, optimization, and validation of automated and semi-automated assembly and packaging processes. Our team is looking for a technical professional who can strengthen manufacturing reliability, support new product introduction, and help ensure robust, compliant, and efficient operations.
Responsibilities:
- Lead technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment, deviation investigations, and root cause analysis.
- Author, execute, and/or approve characterization test protocols, Commissioning, Qualification, and Validation documentation, engineering studies, and technical reports.
- Support process characterization, optimization, validation, and continuous improvement efforts that enhance product quality, process capability, and operational excellence.
- Collaborate cross-functionally with Manufacturing, Quality, Validation, Engineering, and other technical teams to resolve complex technical challenges and support lifecycle management and new product introduction.
Required:
- Demonstrated experience leading Commissioning, Qualification, and Validation activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment.
- Direct experience supporting packaging equipment, combination products, and/or device assembly processes.
- Hands-on experience using electronic quality and document management systems such as KNEAT, Veeva, TrackWise, or equivalent platforms for 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.
- Experience authoring and executing characterization, validation, and engineering test protocols, along with preparing technical reports to support equipment and system qualification and process validation.
- Ability to work autonomously and provide strong technical ownership of commercial manufacturing support, including troubleshooting, process optimization, deviation investigations, and continuous improvement in a regulated environment.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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