Process Validation Engineer

Job Description

Title: Process Validation Engineer

Location : Carlsbad, CA

Duration : 12 months

Temp to Hire potential

8am-5pm

Hybrid - 3 days on-site, 2 days remote

Required Skills: Biological License Application (BLA) filing experience with the FDA/regulatory agencies; Commercial manufacturing experience; Validation activities management

Preferred Skills: Process development or manufacturing experience, Chemistry background, Process development, and manufacturing expertise are high-value additions

Your Role:

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• The Carlsbad Gene Therapy Viral Vector Manufacturing facility is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Process Validation Engineer who will be responsible for developing, reviewing, and managing the execution of validation activities. In this role, you will provide technical leadership within cross-functional teams with primary responsibility as subject matter expert in the strategy for process validation of unit operations within the Carlsbad viral vector manufacturing facilities (CLD-VVM). As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Process and Analytical Development, Quality Control, Quality Assurance, and Project Management teams to ensure successful implementation and coordination of process validation activities.
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• Write risk assessments to assess and identify potential risks associated with various manufacturing processes and facility activities.
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• Assisting in creating process documentation to ensure production processing consistent within validated parameters.
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• Monitor event trends to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents.
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• Acts as a technical liaison, as needed, between process development, manufacturing, external manufacturers and suppliers.
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• Capable of singular project management (within the realm of validation Engineering) for smaller Product validation engineering plans.
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• Evaluate equipment or process problems and design testing to determine possible causes or solutions.
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• Assist in determining process capability of new equipment. Assists in ensuring process development activities have all necessary validation support.
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• The Validation Engineer is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound Qualification/Validation experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.
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• Define and implement process validation framework
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• Implement consistent process qualification, process validation, and continuous process verification (CPV) strategies
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• Define strategy for execution of process performance qualification (PPQ) and product life cycle
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• Generate, review, and approve process validation protocols and reports
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• Lead development of studies around process hold time, homogeneity, mixing etc.
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• Lead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data
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• Lead process validation related investigations
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• Work closely with the client and personnel from Manufacturing, Process Development, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CClient strategies are robust and maintained.
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• Data Management, Generation of Process Validation/CPV documents.
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• Organizes, manages, and interprets data, performs detailed data analysis.
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• Execute complex validation impact assessments with robust rationale
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• Process Validation SME in audits and customer meetings
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• Manage escalation within MSAT, customer and Project Team as it relates to job function and deliverables
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• Self-starter with ability to manage workload with minimal supervision
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• Ability to drive sound decision making
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• Ability to drive project forward with collaboration
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• Comfortable in a fast-paced environment with the ability to adjust to changing priorities
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Who You Are:

Minimum Qualifications:

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• Minimum of 7+ years’ experience in cGMP environment
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• Bachelor’s or master’s degree Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field
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• 5+ years’ experience with process validation, Process Performance Qualification (PPQ) and / or Continued Process Verification (CPV)
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Preferred Qualifications:

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• 10+ years’ experience / subject matter expert (SME) level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV)
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• 5+ years of hands-on experience working directly with cell culture upstream operations (flask expansion, cell stacks, bioreactors, clarification), or downstream purification (TFF (UF/DF), automated chromatography skids (AKTA, XMO), and/or sterile filtration)
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• Ability to lead and influence teams/efforts and processes without direct authority
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• Critical thinking skills that translate into improved outcomes/outputs, and ability to effectively solve and derisk technical problems and form solutions/plans to mitigate issues
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• Familiarity with cGMP document control systems and general procedures
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• Excellent attention to detail, with superior documentation and organization skills
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• Excellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience
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