Process Validation Engineer
Manufacturing
Job Description
Title: Process Validation Engineer
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Location : Carlsbad, CA
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Duration : 12 months
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Temp to Hire potential
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8am-5pm
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Hybrid - 3 days on-site, 2 days remote
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Required Skills: Biological License Application (BLA) filing experience with the FDA/regulatory agencies; Commercial manufacturing experience; Validation activities management
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Preferred Skills: Process development or manufacturing experience, Chemistry background, Process development, and manufacturing expertise are high-value additions
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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.
- Write risk assessments to assess and identify potential risks associated with various manufacturing processes and facility activities.
- Assisting in creating process documentation to ensure production processing consistent within validated parameters.
- Monitor event trends to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents.
- Acts as a technical liaison, as needed, between process development, manufacturing, external manufacturers and suppliers.
- Capable of singular project management (within the realm of validation Engineering) for smaller Product validation engineering plans.
- Evaluate equipment or process problems and design testing to determine possible causes or solutions.
- Assist in determining process capability of new equipment. Assists in ensuring process development activities have all necessary validation support.
- 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.
- Define and implement process validation framework
- Implement consistent process qualification, process validation, and continuous process verification (CPV) strategies
- Define strategy for execution of process performance qualification (PPQ) and product life cycle
- Generate, review, and approve process validation protocols and reports
- Lead development of studies around process hold time, homogeneity, mixing etc.
- Lead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data
- Lead process validation related investigations
- 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.
- Data Management, Generation of Process Validation/CPV documents.
- Organizes, manages, and interprets data, performs detailed data analysis.
- Execute complex validation impact assessments with robust rationale
- Process Validation SME in audits and customer meetings
- Manage escalation within MSAT, customer and Project Team as it relates to job function and deliverables
- Self-starter with ability to manage workload with minimal supervision
- Ability to drive sound decision making
- Ability to drive project forward with collaboration
- Comfortable in a fast-paced environment with the ability to adjust to changing priorities
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Who You Are:
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Minimum Qualifications:
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- Minimum of 7+ years’ experience in cGMP environment
- Bachelor’s or master’s degree Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field
- 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)
- 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)
- Ability to lead and influence teams/efforts and processes without direct authority
- 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
- Familiarity with cGMP document control systems and general procedures
- Excellent attention to detail, with superior documentation and organization skills
- 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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