Software and Equipment Validations Engineer

Software and Equipment Validations 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

• This role will be primarily responsible for planning, executing, and documenting validation activities to ensure that systems, processes, products, or equipment meet quality, safety, and regulatory standards; implementing validation expertise to meet validation objectives; developing validation plans that outline the scope, objectives, resources, and timelines for validation activities.
• Ideal candidate has a strong software validations background and is comfortable with project management and ownership.

RESPONSIBILITIES:

Qualifications (IQ/OQ/PQ)

• Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
• Develops and maintains databases for tracking test results, validation activities, or validated systems.
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.
• Modifies testing methods or revisits test objectives and standards to resolve testing problems.
• Calibrates equipment to ensure accurate measurements.

Manufacturing Process Validations

• Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.
• Assist in failure investigations and root cause analyses as they relate to process performance.
• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.

REQUIREMENTS:

Required Experience:

• BS/BA in engineering or other technical field
• Minimum 7 years experience in an engineering function dealing with validating processes within equipment and software environment.
• 3-5 years of experience in a GMP or ISO 9001/13485 environment

Additional Experience:

• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
• Knowledge of cGMP manufacturing, cell culture, aseptic processing and process validations.
• Proven experience with DOE’s, root cause analysis, process engineering, and failure investigations.
• Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.

Additional Skills:

• Ability to independently develop and manage projects and timelines.
• Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.
• Strong attention to detail and process mindset.
• Ability to exercise independent judgment consistent with Company guidelines.
• Excellent verbal and written communication skills.
• Familiar with statistical process control methods.

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.

The pay range for this role is: 100,000 - 120,000 USD per year (San Diego, CA)