Specialist, Engineering (Onsite)
Core
On-site engineering support for non-sterile formulation, laboratory, and experimentation operations in pharmaceutical research labs, ensuring equipment compliance and operational continuity.
Role type
Specialist, Engineering (Onsite)
Builds
Clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products
Domain
Biopharmaceuticals / Pharmaceutical Manufacturing
Deliverable
infrastructure
Required skills
cGMP compliance, equipment troubleshooting (mechanical/electrical/automation), CMMS familiarity, process validation, change management, deviation investigation, root cause analysis, CAPA management, GMP documentation, capital project coordination
Preferred skills
SAP Plant Maintenance, eVal/Kneat validation system, ProCal calibration system, planning and scheduling, independent problem-solving
Technologies
CMMS, eVal/Kneat, ProCal, SAP
Responsibilities
Maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements; troubleshoot equipment and partner with vendors; support equipment validation from commissioning through decommissioning; manage changes, periodic reviews, and deviations; issue Quality Notifications and identify root causes; maintain GMP documentation; coordinate installation and commissioning of new equipment; support regulatory interactions as an SME.
Seniority
Specialist, hands-on IC
