Principal Engineer, Tech Ops

CSL

11h

About The Position

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.

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.
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.

Responsibilities

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.