Manager, Principal Compliance Engineer
Core
Lead a team to perform periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state within an FDA-regulated pharmaceutical environment.
Role type
Senior IC compliance engineer (equipment commissioning & qualification)
Builds
Validated equipment and departmental compliance processes
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
cGMP, GXP, GAMP, SDLC, 21CFR part 11, computer systems validation, gap analysis, regulatory guidelines (FDA, EMA, USP, EP, JP), calibration management, environmental monitoring systems
Preferred skills
Quality assurance experience, project leadership, presentation development
Technologies
Microsoft Office Suite, database systems
Responsibilities
Perform gap analyses on existing equipment and technologies; Review new equipment and technologies to ensure compliance; Participate in revisions of departmental procedures to maintain compliance; Support or lead Historical Performance Review (HPR) investigations and deviations; Participate in and prepare for internal and external audits
Seniority
Principal, hands-on IC with team leadership