Process Engineer

Temp to hire potential 8am-5pm Hybrid - 3 days on-site, 2 days remote

Required Skills

• Biological License Application (BLA) fi ling 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

Summary

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.

Responsibilities

• 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 scope 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 CMC 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 work load 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

Minimum Qualifications

• 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)

Preferred Qualifications

• 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