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
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