Process Validation Engineer

Pay Rate: $57.00 - $72.00/hour - Determined based on experience (Paid Weekly)

Work Model: Hybrid – 3 days onsite, 2 days remote Employment Potential: Temp-to-hire potential.

Note: This is a W2 only role — C2C, C2H will not be considered

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 Summary of the Role: BEPC is seeking a highly motivated Process Validation Engineer to join our client’s site in Carlsbad, CA. This role will support a Gene Therapy Viral Vector Manufacturing facility that produces drug substances and drug products for gene therapy and oncology applications. The Process Validation Engineer will be responsible for developing, reviewing, and managing the execution of validation activities. This role will provide technical leadership within cross-functional teams, with primary responsibility as a subject matter expert in the strategy for process validation of unit operations within viral vector manufacturing facilities. The successful candidate will work cross-functionally with Manufacturing, Process and Analytical Development, Quality Control, Quality Assurance, and Project Management teams to ensure successful implementation and coordination of process validation activities. The Process Validation Engineer is responsible for the design, scheduling, execution, and evaluation of scientifically and statistically sound Qualification/Validation experiments that define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes, and Utilities function in a consistent and repeatable manner and comply with regulatory requirements, product license restrictions, and policies affecting final product integrity. Summary of

Duties and Responsibilities: Write risk assessments to assess and identify potential risks associated with various manufacturing processes and facility activities. Assist in creating process documentation to ensure production processing is consistent within validated parameters. Monitor event trends to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents. Act as a technical liaison, as needed, between Process Development, Manufacturing, external manufacturers, and suppliers. Manage smaller-scope validation engineering plans within the realm of Validation Engineering. Evaluate equipment or process problems and design testing to determine possible causes or solutions. Assist in determining process capability of new equipment. Assist in ensuring Process Development activities have all necessary validation support. Define and implement a 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 lifecycle. 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 personnel from Manufacturing, Process Development, Quality Control, Quality Assurance, Operations, and Project Management to ensure scientific and CMC strategies are robust and maintained. Manage data and generate Process Validation/CPV documents. Organize, manage, and interpret data and perform detailed data analysis. Execute complex validation impact assessments with robust rationale. Serve as the Process Validation SME in audits and customer meetings. Manage escalation within MSAT, customer, and Project Team as it relates to job function and deliverables. Manage workload with minimal supervision. Drive sound decision-making. Drive projects forward through collaboration. Work effectively in a fast-paced environment and adjust to changing priorities.

Main Qualifications: Education: Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or another Life Science-related field. Minimum of 7+ years of experience in a cGMP environment.5+ years of experience with process validation, Process Performance Qualification (PPQ), and/or Continued Process Verification (CPV).

Preferred Qualifications: 10+ years of experience / SME-level understanding of 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, including flask expansion, cell stacks, bioreactors, and clarification, or downstream purification, including 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, with the ability to effectively solve and de-risk technical problems and develop solutions/plans to mitigate issues. Familiarity with cGMP document control systems and general procedures. Excellent attention to detail, with superior documentation and organizational skills. Excellent computer, verbal, and written communication skills, including strong technical writing ability and demonstrated ability to communicate scientific ideas to a broader cross-functional technical/non-technical audience. About BEPCBEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. Apply Now! Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!