Senior Engineer, Validation
Core
Lead maintenance, engineering, and validation activities for clinical packaging equipment, facilities, and utilities to ensure product quality and regulatory compliance.
Role type
Senior IC validation engineer (pharmaceutical packaging)
Builds
Validated clinical packaging equipment and facilities
Domain
Pharmaceutical manufacturing / Clinical packaging
Required skills
Validation Master Plan management, equipment validation, facility validation, utility validation, change control documentation, process improvement, SOP development, team supervision, regulatory compliance, vendor management
Preferred skills
Experience with VMS systems, knowledge of pharmaceutical packaging equipment, financial system proficiency
Technologies
VMS, electronic tracking systems (via careerplan.io/jobs/3743990015926606-senior-engineer-validation-at-abbvie)
Responsibilities
Manage departmental capital projects and engineering activities; Execute equipment, facility, utility, and cleaning validation activities; Maintain Validation Master Plan and manage change control; Investigate and resolve issues related to equipment and facilities; Supervise engineering technicians and contract staff; Represent department in quality audits; Initiate change requests for SOPs; Balance short-term production needs with long-term strategic objectives.
Seniority
Senior, hands-on IC