Validation Engineer II
Evotec
Senior Process Validation Engineer
Evotec
full-time
Posted on:
Location Type: Office
Location: Redmond • Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $112,560 - $154,100 per year
Job Level
Senior
About the role
- 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.
- 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
- Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites
Requirements
- Bachelor’s degree in engineering science or related program
- 10+ years relevant experience or 8+ years of relevant experience with an MS
- 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
- 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
- Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
- Experience leading technical projects and managing timelines with external collaborators and vendors
- Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skill
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off and paid holiday
- wellness and transportation benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Process ValidationTech TransferProcess Performance Qualification (PPQ)Process CharacterizationGMPContinuous Process MonitoringStatistical AnalysisRegulatory CMC DocumentationManufacturing Technical DocumentsProcess Control Strategy
Soft skills
LeadershipOrganizational SkillsAnalytical SkillsCommunication SkillsInterpersonal SkillsCollaborationMentoringAttention to DetailTime ManagementStrategic Mindset
Certifications
Bachelor’s Degree in Engineering ScienceMaster’s Degree in Related Program