Senior Quality Engineer

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.
• Assist with investigations related to EM excursions, initiating appropriate corrective actions as needed.

Product Release Support

• Review batch records, manufacturing documentation, and associated data to ensure accuracy, completeness, and compliance with established procedures and regulatory requirements.
• Support the execution and/or review of Quality Control related activities necessary for raw material and finished good releases.

Operational Excellence

• Conduct analyses of existing quality and business processes to identify inefficiencies, bottlenecks, and areas for improvement.
• Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing operational efficiency and effectiveness.
• Partner with senior leadership to align Operational Excellence initiatives with strategic business objectives and priorities.
• Develop and monitor key performance indicators (KPIs) to demonstrate and communicate the results of improvement initiatives.
• Support the development and delivery of training related to quality processes and improvement activities.

Qualifications

EDUCATION: 

• Bachelor’s degree in Life Sciences, Microbiology, Biology, or a related field. A combination of education and/or relevant job experience may be considered.

REQUIRED EXPERIENCE: 

• 5-7 years of experience within the pharmaceutical, biotechnology, or related regulated industry.
• Experience with environmental monitoring, water testing, and microbiological/chemical testing methodologies preferred. Including familiarity with gowning practices to execute processes within an ISO 5 and ISO 7 environment.
• Strong organizational skills with attention to detail and the ability to manage multiple tasks.
• Experience managing stability programs, including protocol authorship, study execution oversight, and report generation.
• Familiarity with Aseptic Process Validation (e.g., Media Fill programs) and process/equipment qualification activities (IQ/OQ/PQ).
• Strong knowledge of GMP, ISO (9001/13485), USP standards and applicable regulatory requirements related to EM, stability, and validation.
• Ability to execute routine testing such as pH, Conductivity, Endotoxin, Density, Osmolality and Appearance.
• Experience with Quality Management Systems (QMS) and electronic documentation platforms.
• Excellent problem-solving, analytical, and organizational skills with a high attention to detail.
• Strong communication and leadership abilities, with experience collaborating across cross-functional teams.

ADDITIONAL SKILLS:

• Ability to independently develop and manage projects and timelines
• Familiarity with the execution of Celsis testing is a plus

PHYSICAL REQUIREMENTS: 

• Ability to hear and speak to employees and external associates on the phone and in person. 
• Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) 
• Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions 
• [for manufacturing positions only] Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis. 

TRAVEL REQUIREMENTS: 

• May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position. 

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.