Engineer I ( Engineering Compliance)
Core
Ensuring GMP compliance for engineering systems, facilities, and utilities through oversight, investigations, and change control in a biopharmaceutical manufacturing environment.
Role type
Entry-level Engineering Compliance Engineer (Manufacturing)
Builds
Compliant engineering systems, facilities, and utilities for biopharmaceutical production
Domain
Biopharmaceutical manufacturing / cGMP compliance
Deliverable
client delivery
Required skills
GMP compliance knowledge, engineering investigations, change control management, CAPA management, deviation triage, regulatory inspection readiness, root cause analysis, vendor/contractor management
Preferred skills
Commercial manufacturing experience, pharmaceutical/biologics industry background, regulatory audit experience, problem-solving with data analysis
Technologies
None explicitly stated
Responsibilities
Provide Engineering Compliance oversight and interface with Quality Assurance; Support complex facility and engineering GMP compliance investigations; Lead deviation triage and investigations for Facilities & Engineering; Manage closure of F&E DQMS records (NCs, CAPAs, Change Control); Coordinate inspection readiness activities and GEMBA walkdowns; Represent department in inspection readiness meetings and internal audits; Lead support for regulatory inspection triage and response preparation
Seniority
Entry-level (Engineer I)