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Senior Principal Aseptic Engineer
DayforceSenior Principal Aseptic Engineer overseeing aseptic manufacturing and deviation investigations. Leading cross-functional compliance initiatives and supporting quality assurance in sterile environments.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in aseptic processing, contamination control, and regulatory compliance, with a strong focus on leading deviation investigations and CAPA programs. Proven ability to drive cross-functional collaboration and continuous improvement initiatives using Lean and Six Sigma methodologies.
Highest-signal resume keywords
Aseptic Processing ExpertiseDeviation Investigation LeadershipCAPA Program ManagementLean Six Sigma CertificationRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause AnalysisContamination Control StrategiesProcess ValidationEnvironmental MonitoringData Analytics
Soft Skills
LeadershipMentoringCross-Functional CollaborationProblem-Solving
Tools & Technologies
TrackWiseVeeva
Certifications & Qualifications
Lean Six Sigma Black Belt
Industry Keywords
Aseptic ManufacturingSterile Product QualityRegulatory InspectionsQuality AssuranceCleanroom Operations
About the role
Key responsibilities & impact- Lead and oversee complex, high-risk deviation investigations impacting aseptic processing and sterile product quality
- Establish and standardize investigation methodologies, ensuring consistent application of advanced root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree Analysis, FMEA)
- Provide strategic direction and governance for the CAPA program, ensuring effectiveness, timeliness, and sustainability of actions
- Act as the aseptic processing SME during regulatory inspections, audits, and client interactions
- Drive cross-functional alignment between Manufacturing, Quality Assurance, Microbiology, Validation, and Engineering
- Analyze and trend process, deviation, and environmental monitoring data to identify systemic risks and implement preventive strategies
- Lead risk assessments related to contamination control, sterility assurance, and process robustness
- Champion continuous improvement initiatives using Lean, Six Sigma, and operational excellence principles
- Mentor and develop junior staff and investigation teams, building organizational capability in problem-solving and compliance
- Support process validation, media fills, and aseptic simulations by ensuring robust issue resolution and risk mitigation
- Review and approve critical quality documentation, including deviation reports, investigation summaries, and CAPA plans
- Partner with senior leadership to prioritize and resolve critical quality and operational risks
Requirements
What you’ll need- Bachelor’s Degree in Microbiology, Biology, Chemistry, Engineering, related field or equivalent experience
- 15+ years of experience in aseptic/sterile manufacturing
- Deep expertise in aseptic processing, contamination control strategies, and cleanroom operations
- Extensive experience leading complex deviation investigations and CAPA programs
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH, PIC/S)
- Demonstrated leadership in cross-functional environments
- Advanced Degree
- Lean Six Sigma certification (Black Belt preferred)
- Experience leading regulatory inspections and responding to audit findings
- Familiarity with advanced data analytics tools and digital quality systems (e.g., TrackWise, Veeva)
- Bilingual in Spanish
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Dayforce Website LinkedIn All Job Openings 5001 - 10000 employees 👥 HR Tech ☁️ SaaS 🏢 Enterprise 💰 $1G Post-IPO Debt - Dayforce on 2024-03 HR Tech
- SaaS
- Enterprise Dayforce is a cloud-based human capital management (HCM) platform (offered by Ceridian) that combines payroll, HR, time & attendance/workforce management, benefits, talent management, and analytics in a single SaaS application. It is designed to help HR and payroll teams manage workforce processes for mid-market and enterprise customers, delivering real-time payroll processing, compliance, scheduling, and employee lifecycle features. Senior Principal Aseptic Engineer Job not on LinkedIn 🔥 21 minutes ago 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧑💻 Full-stack Engineer 🗣️🇪🇸 Spanish Required Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Lead and oversee complex, high-risk deviation investigations impacting aseptic processing and sterile product quality
- Establish and standardize investigation methodologies, ensuring consistent application of advanced root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree Analysis, FMEA)
- Provide strategic direction and governance for the CAPA program, ensuring effectiveness, timeliness, and sustainability of actions
- Act as the aseptic processing SME during regulatory inspections, audits, and client interactions
- Drive cross-functional alignment between Manufacturing, Quality Assurance, Microbiology, Validation, and Engineering
- Analyze and trend process, deviation, and environmental monitoring data to identify systemic risks and implement preventive strategies
- Lead risk assessments related to contamination control, sterility assurance, and process robustness
- Champion continuous improvement initiatives using Lean, Six Sigma, and operational excellence principles
- Mentor and develop junior staff and investigation teams, building organizational capability in problem-solving and compliance
- Support process validation, media fills, and aseptic simulations by ensuring robust issue resolution and risk mitigation
- Review and approve critical quality documentation, including deviation reports, investigation summaries, and CAPA plans
- Partner with senior leadership to prioritize and resolve critical quality and operational risks 🎯 Requirements
- Bachelor’s Degree in Microbiology, Biology, Chemistry, Engineering, related field or equivalent experience
- 15+ years of experience in aseptic/sterile manufacturing
- Deep expertise in aseptic processing, contamination control strategies, and cleanroom operations
- Extensive experience leading complex deviation investigations and CAPA programs
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH, PIC/S)
- Demonstrated leadership in cross-functional environments
- Advanced Degree
- Lean Six Sigma certification (Black Belt preferred)
- Experience leading regulatory inspections and responding to audit findings
- Familiarity with advanced data analytics tools and digital quality systems (e.g., TrackWise, Veeva)
- Bilingual in Spanish Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Software Engineer 🔥 9 minutes ago Stretto 201 - 500 ⚖️ Legal 💸 Finance Website LinkedIn All Job Openings Full Stack Software Engineer designing, developing, and maintaining enterprise applications for Stretto's engineering team. Collaborating across teams to deliver high-quality, efficient software solutions. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🧑💻 Full-stack Engineer Angular AWS Cloud EC2 Hibernate Java JavaScript Node.js Python React Spring SQL TypeScript Senior Software Engineer, Full-Stack 🔥 21 minutes ago Mem 11 - 50 ☁️ SaaS ⚡ Productivity 🤖 Artificial Intelligence Website LinkedIn All Job Openings Senior Full-Stack Engineer building high-quality experiences for AI Thought Partner. Solving complex technical challenges with strong autonomy while crafting excellent user experiences. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧑💻 Full-stack Engineer Senior/Staff Software Engineer 🔥 22 minutes ago Maven 11 - 50 📚 Education 🏪 Marketplace 👥 B2C Website LinkedIn All Job Openings Full-stack product engineer owning key components of Maven's growing marketplace. Collaborate with a talented team to deliver value in product development and system architecture. 🇺🇸 United States – Remote 💵 $170k - $220k / year 💰 $20M Series A - Maven on 2021-05 ⏰ Full Time 🟠 Senior 🧑💻 Full-stack Engineer Postgres React Lead Software Engineer, Dashboard Build 🔥 42 minutes ago Cisco 10,000+ employees 🔧 Hardware 🔐 Security Website LinkedIn All Job Openings Lead Software Engineer focusing on architecture and technical direction for compliant build systems. Collaborating across teams to support Cisco's FedRAMP High and DoD requirements. 🇺🇸 United States – Remote 💵 $186.9k - $267.7k / year ⏰ Full Time 🟠 Senior 🧑💻 Full-stack Engineer AWS Docker Groovy JavaScript Jenkins Kubernetes Python React RSpec Ruby Ruby on Rails TypeScript Integrated Photonics Technical Leader 🔥 42 minutes ago Cisco 10,000+ employees 🔧 Hardware 🔐 Security Website LinkedIn All Job Openings Integrated Photonics Technical Leader working on photonic components and collaborating with PIC team at Acacia. Responsible for design, simulation, layout and testing of photonic circuits. 🇺🇸 United States – Remote 💵 $191.4k - $281.4k / year ⏰ Full Time 🟠 Senior 🧑💻 Full-stack Engineer View More Full-stack Engineer Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs