Equipment Validation Engineer
Accentuate Staffing is partnering with a fast-growing, CDMO who is in search of an Equipment Validation Engineer to join their team. This is a direct hire opportunity, offering competitive pay while working onsite. The ideal candidate has the ability to provide technical expertise and guidance to support the operations of Manufacturing, Packaging and Maintenance departments while actively troubleshooting issues and driving sustainable improvement initiatives.
Responsibilities:
- Supports manufacturing and packaging departments through capital projects and continuous improvement initiatives.
- Leads critical capital projects, supports new product launches, and represents the Engineering department in both internal and external forums.
- Develops and implements qualification documents in compliance with GMP and Validation Master Plans.
- Leads and drives strategic engineering projects by applying effective project management principles, including identification, justification, risk assessment, ROI analysis, and management of cost, time, scope, and resources.
- Provides senior engineering support and leads troubleshooting efforts on the production floor in collaboration with the Maintenance department.
Requirements:
- Bachelor’s or master’s degree in an Engineering related discipline combined with 4+ years of GMP-regulated, pharmaceutical manufacturing experience.
- Extensive experience performing equipment validations, implementing new technologies, ensuring validation readiness and optimizing processes for operational excellence.
- Familiarity with liquid and semi-solid dose manufacturing is highly preferred.
- High proficiency in the qualification and validation of equipment, facilities, and processes combined with the ability to independently prepare qualification documentation.
- Strong knowledge of project management principles including project identification, justification, risk assessment, ROI analysis, cost control, time management, scope definition, and resource allocation.
