Senior Quality Engineer

About Nucleus Biologics:

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. 

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. 

About the role

The Senior Quality Engineer is responsible for ensuring compliance with regulatory requirements (i.e. ISO 9001, ISO 13485, and EXCiPACT) and internal quality standards. This role leads the Environmental Monitoring and Stability programs, provides critical support for Aseptic Process Validation and Process/Equipment Validation activities, and drives Operational Excellence initiatives. The Senior Quality Engineer works cross-functionally to uphold the highest standards of product quality and continuous improvement. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs.

What you'll do

RESPONSIBILITIES:

Stability Program Oversight

• Manage the end-to-end stability program, including onboarding new studies, maintaining the stability schedule, and ensuring timely execution of all stability protocols.
• Author and review stability study protocols, ensuring alignment with regulatory requirements and product-specific objectives.
• Ensure the timely completion of stability testing by coordinating with internal and external testing needs.
• Review stability data and results throughout the study lifecycle, identifying trends and flagging out-of-trend or out-of-specification results for investigation.
• Complete interim and final stability reports as required, ensuring accuracy, completeness, and regulatory compliance.
• Maintain stability program documentation within the Quality Management System (QMS).

Aseptic Process Validation Support

• Support aseptic process validation (APV) activities, including Media Fills and related studies, in collaboration with the Validation and Manufacturing teams.
• Author and review APV protocols, ensuring scientific rigor and alignment with current regulatory guidance (e.g., FDA Aseptic Processing Guidance, Annex 1).
• Conduct thorough review of executed APV protocols, verifying data integrity and compliance with acceptance criteria.
• Generate and finalize APV summary reports, ensuring all deviations, investigations, and conclusions are appropriately documented.
• Serve as the Quality point of contact for aseptic process validation inquiries and regulatory submissions as needed.

Process & Equipment Validation Support

• Collaborate cross-functionally with the Validation team to support the creation, review, and routing of process and equipment validation protocols and reports.
• Provide Quality oversight and approval for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
• Ensure validation activities align with applicable regulatory requirements, internal SOPs, and industry best practices.
• Participate in risk assessments and validation planning activities to prioritize and scope validation efforts appropriately.
• Support the resolution of validation-related deviations and contribute to continuous improvement of the validation program.

Environmental Monitoring

• Execute and support Environmental Monitoring (EM) program in accordance with established protocols and regulatory requirements. This includes routing EM, personnel monitoring and water sampling.
• Assist with the review and analysis of EM, personnel monitoring, and water testing data to identify trends, adverse events, and opportunities for improvement