Process Engineer

Lancesoft; Carlsbad (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Lancesoft is seeking a Process Validation Engineer for the Carlsbad gene therapy viral vector facility. You will develop, review, and manage validation activities and serve as SME for process validation across unit operations, interfacing with Manufacturing, Quality, and Project Management.

Responsibilities include risk assessments, protocol generation, data interpretation, and cross-functional leadership to ensure compliant, robust validation strategies within a fast-paced CDMO environment.

Qualifications

• BLA filing experience with FDA/regulatory agencies.
• Minimum 7+ years in a cGMP environment.
• Process validation, PPQ and CPV experience.

Responsibilities

• Write risk assessments for manufacturing processes and facilities.
• Create and review validation documentation to ensure validated parameters.
• Monitor events and propose corrective actions to avoid repeats.
• Lead cross-functional validation studies and coordinate with stakeholders.
• Evaluate equipment/process problems and design tests for root cause analysis.

Skills

BLA filing experience

Commercial manufacturing

Validation activities management

Education

Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or Life Science

Job description

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