Principal Engineer, Tech Ops
CSL Behring
Waltham, MA
The Opportunity:
- The Principal Engineer serves as a senior technical expert within Technical Operations, providing end-to-end lifecycle support for products, processes, and systems.
- The role bridges Manufacturing, Engineering, and Quality to ensure robust, compliant, and optimized operations across the global network.
- This position drives continuous improvement, process and technology stewardship, data driven decision making, and cross functional technical leadership, while ensuring alignment with evolving enterprise strategies, global standards, and modern ways of working.
The Role:
- Technical Leadership & Lifecycle Stewardship: 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.
- Operational Support & Problem Solving: 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.
- Data Analytics & Risk Based Decision Making: 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.
- Project & Portfolio Execution: Lead or contribute to S&I and OPEX/CAPEX projects, ensuring technical excellence, compliance, and alignment with industry standards.
- Support conceptual design, user requirements, and process documentation (PFDs, P&IDs, system descriptions).
- Process & Technology Optimization: Identify and execute continuous improvement initiatives focused on yield, quality, reliability, efficiency, and cost.
- Contribute to global harmonization efforts and the development of standardized processes, templates, and best practices.
- Validation: Develop and execute scientifically sound, risk-based validation strategies for equipment, systems, or processes.
- Ensure documentation meets regulatory expectations and supports global submissions.
- Audit & Inspection Readiness: Provide technical support during internal and external inspections, ensuring clear articulation of process, engineering, or validation rationales.
- Collaboration & Stakeholder Engagement: Work cross functionally with Manufacturing, Quality, Engineering, R&D, and Global Functions.
- Act as a facilitator between local operational teams and global technical stakeholders to enable consistent, enterprise-wide standards.
- Safety & Compliance: Act as a role model for safety, adhering to all site guidelines, proactively mitigating risks, and supporting a culture of safety excellence.
Skills & Experience:
- 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.
- Leadership
- Builds Bridges: Shares information proactively; collaborates across functions.
- Unleash Outcomes: Takes accountability for delivering results.
- Ignite Agility: Adjusts priorities to meet changing operational needs.
- Technical: Process engineering fundamentals (risk assessment, troubleshooting, equipment qualification).
- Data literacy and analytical decision-making.
- Knowledge of GMP operations, deviation management, validation, and lifecycle management.
- Strong communication, cross-functional partnering.
- Problem solving, resilience, attention to detail.
- Continuous improvement mindset.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.