Process Validation Engineer
Listed on 2026-10-12
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Engineering
Quality Engineering, Process Engineer, Validation Engineer
W2 Contract – 12 months with possible extensions!
Benefits include medical, dental, vision, and life insurance
Pay Rate: $57.00 - $72.00/hour -
Determined based on experience (Paid Weekly)
Work Model:Hybrid – 3 days onsite, 2 days remoteNote
This is a W2 only role — C2C, C2H will not be considered
Required SkillsBiological License Application (BLA) filing experience with the FDA/regulatory agencies | Commercial manufacturing experience | Validation activities management
Preferred SkillsProcess development or manufacturing experience | Chemistry background | Process development and manufacturing expertise
Summary of the RoleBEPC 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…
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