Process Validation Engineer

Job Description

BEPC is actively looking for Process Validation Engineer, in Carlsbad, CA area!

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W2 Contract – 12 months with possible extensions!

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Benefits include medical, dental, vision, and life insurance

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

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Work Model: Hybrid – 3 days onsite, 2 days remote

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Employment Potential: Temp-to-hire potential.

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

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Required Skills

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Biological License Application (BLA) filing experience with the FDA/regulatory agencies | Commercial manufacturing experience | Validation activities management

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Preferred Skills

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Process development or manufacturing experience | Chemistry background | Process development and manufacturing expertise

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Summary of the Role:

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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.

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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.

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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.

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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.

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Summary of Duties and Responsibilities:

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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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• Assist in creating process documentation to ensure production processing is 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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• Act as a technical liaison, as needed, between Process Development, Manufacturing, external manufacturers, and suppliers.
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• Manage smaller-scope validation engineering plans within the realm of Validation Engineering.
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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.
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• Assist in ensuring Process Development activities have all necessary validation support.
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• Define and implement a 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 lifecycle.
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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 personnel from Manufacturing, Process Development, Quality Control, Quality Assurance, Operations, and Project Management to ensure scientific and CMC strategies are robust and maintained.
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• Manage data and generate Process Validation/CPV documents.
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• Organize, manage, and interpret data and perform detailed data analysis.
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• Execute complex validation impact assessments with robust rationale.
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• Serve as the 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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• Manage workload with minimal supervision.
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• Drive sound decision-making.
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• Drive projects forward through collaboration.
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• Work effectively in a fast-paced environment and adjust to changing priorities.
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Main Qualifications:

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• Education: Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or another Life Science-related field.
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• Minimum of 7+ years of experience in a cGMP environment.
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• 5+ years of 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 of experience / SME-level understanding of 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, including flask expansion, cell stacks, bioreactors, and clarification, or downstream purification, including 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, with the ability to effectively solve and de-risk technical problems and develop 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 organizational skills.
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• 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.
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About BEPC

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BEPC 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.

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Apply Now!

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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!