Just Evotec Biologic is looking for a Senior Process Validation Engineer to provide project leadership for process validation and tech transfer activities for late-stage programs into commercial biologics manufacturing. The role will support the implementation of network alignment strategy, creation of global templates/documentation for Process Validation, and assist with new facility startup, performance qualification runs, regulatory submissions, and inspections.
Requirements
- Proven experience in leading Process Validation activities for late-stage clinical manufacturing, PPQ campaigns/ commercial campaign support.
- Understanding of GMP concepts and Quality systems necessary to execute process validation activities.
- Experience developing and providing oversight to Continuous Process Monitoring strategies and Process Validation status throughout commercial lifecycle.
- Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
- Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
- Solid background in statistical analysis
- Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
Responsibilities
- Project Lead for Process Validation and/or Tech Transfer activities of late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
- Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
- In collaboration with cross functional teams, develop Process Validation Master Plans, provide process knowledge to support Process Characterization, and perform Process Validation risk assessments.
- Support development, review and approval of technical documentation including global protocols for Process Performance Qualification runs, Process Validation studies, and associated reports related to engineering, GMP and PPQ runs.
- Support the development and implementation of templates for Process Validation and Continued Process Verification strategies.
- Support the generation of governance policies and related SOPs for Process Validation
- Manage project-specific deliverables including but not limited to PVMP, PPQ protocols and supporting validation such as mixing, hold time studies, impurity clearance, extractables & leachables, filter validation etc.
Other
- Bachelor’s degree in engineering science or related program with 10+ years relevant experience or 8+ years of relevant experience with an MS.
- Strategic mindset, ability to organize, analyze/interpret, and effectively translate process validation expertise into global procedures/templates
- Good interpersonal, team, and collaborative skills
- Excellent oral and written communication skills
- Demonstrated skills managing or mentoring junior engineers or direct reports.
