Engineer I
Core
Support manufacturing activities for cGMP equipment and facilities, ensuring equipment performance, reliability, and safety compliance.
Role type
Entry-level manufacturing engineer (IC)
Builds
Reliable pharmaceutical/biotech production equipment and facilities
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
infrastructure
Required skills
Equipment reliability management, cGMP compliance, validation protocol execution, risk-based verification, continuous improvement, regulatory inspection support, capital project support
Preferred skills
Process equipment knowledge (cell culture, fermentation, purification), process automation fundamentals, Delta V/Rockwell/Plant Information Systems, Lean/Six Sigma methodologies, SOP development
Technologies
Delta V, Rockwell, Plant Information Systems
Responsibilities
Ensure consistent equipment performance and reliability; execute and document validation protocols per cGMP; drive continuous improvement projects; act as liaison between Engineering, Automation, Maintenance, and QA; support capital projects and business cases; mentor project teams on risk-based approaches; defend calibration and validation during regulatory inspections.
Seniority
Entry-level, hands-on IC