Engineering Compliance Specialist

About the role

The Engineering Compliance Specialist ensures that engineering operations within Viatris meet all regulatory, quality, and safety standards. This position supports the Operations Maintenance area by managing SOP revisions, CAPAs, QARs, and audit activities.

Key responsibilities

• Act as the primary engineering contact for internal and external regulatory audits and inspections.
• Support the Engineering Maintenance Unit in achieving QA, EHS, DEA, and other regulatory commitments, including QARs, CAPAs, and corrective actions.
• Define and lead training programs for maintenance staff and subcontractors, tracking compliance through corporate learning platforms.
• Generate calibration alerts, maintain calibration records, and ensure work order documentation meets regulatory metrics.
• Develop, revise, and implement departmental SOPs, policies, and manuals.
• Lead root‑cause investigations, document corrective actions, and drive quality improvement plans.

Required profile

• B.S. in Engineering (Chemical, Civil, Electrical, Industrial, or Mechanical).
• Minimum eight (8) years of compliance experience in pharmaceutical engineering environments.
• Strong knowledge of GMP, OSHA, FDA, and other relevant pharmaceutical regulations.
• Experience with CAPA, QAR, CR processes and regulatory audit support.

Required skills

• Six Sigma DMAIC certification (highly desirable).
• Technical writing certification.
• Proficiency with Trackwise investigation system.
• Root‑cause analysis and corrective‑action documentation.
• Calibration management and SOP revision expertise.

What we offer

• Competitive salary and comprehensive benefits.
• Inclusive work environment that values diverse perspectives.
• Opportunities to impact the health of millions worldwide.