Principal Engineer, Tech Ops
CSL
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • United States
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Job Level
About the role
- Provide subject matter expertise to ensure process, equipment, and product performance throughout the lifecycle.
- Serve as a technical reference for complex or nonroutine manufacturing and engineering topics.
- Support or lead technology transfer, scaleup/down, modernization, and lifecycle management initiatives.
- Support daily operations by troubleshooting process and equipment issues, using structured root cause methodologies and data analytics.
- Ensure timely closure of deviations, CAPAs, change controls, and regulatory commitments.
- Analyze production and analytical data to identify trends, risks, or improvement opportunities.
- Apply risk assessment tools (FMEA, PRA) in deviation assessments, validation approaches, and design decisions.
- Lead or contribute to S&I and OPEX/CAPEX projects, ensuring technical excellence, compliance, and alignment with industry standards.
- Identify and execute continuous improvement initiatives focused on yield, quality, reliability, efficiency, and cost.
- Develop and execute scientifically sound, risk-based validation strategies for equipment, systems, or processes.
- Provide technical support during internal and external inspections, ensuring clear articulation of process, engineering, or validation rationales.
- Work cross functionally with Manufacturing, Quality, Engineering, R&D, and Global Functions.
Requirements
- Bachelor’s, Master’s, or PhD in Engineering or Life Sciences.
- Minimum 5 years of experience in Process Engineering, MS&T, Process Technology, Validation, or similar technical roles in the pharmaceutical, biotech, or chemical industry.
- Experience in GMP regulated environments and cross functional project teams.
- Strong technical problem solving, data analytics, communication, and stakeholder management skills.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process engineeringdata analyticsrisk assessmentFMEAPRAvalidation strategiestroubleshootingcontinuous improvementGMPtechnical problem solving
Soft Skills
communicationstakeholder managementcross-functional collaborationleadershiporganizational skillsanalytical thinkingtechnical expertiseprocess articulationproject managementteamwork