Senior Engineer, Validation (Temporary Position)
Core
Lead maintenance, engineering, and validation activities for equipment, facilities, utilities, and cleaning to ensure product quality meets R&D and Corporate Quality Standards.
Role type
Senior Validation Engineer/Analyst
Builds
Validation documentation, change control records, and compliance reports for pharmaceutical manufacturing equipment and facilities.
Domain
Pharmaceutical/Biopharmaceutical manufacturing and engineering
Deliverable
client delivery
Required skills
Validation Master Plan (VMP) management, validation change control, equipment/facility/utility validation, process improvement initiatives, regulatory compliance, document review, SOP change requests, EH&S management system compliance
Preferred skills
BS in engineering or related science, 6+ years in validation/engineering within pharmaceutical area, knowledge of DMS, understanding of pharmaceutical packaging equipment and BDS equipment
Technologies
Documents Management System (DMS)
Responsibilities
Manage departmental capital projects and miscellaneous engineering activities; coordinate required services with in-house functional support and outside vendors; maintain the Validation Master Plan (VMP); manage validation related, quality improvement projects to foster compliance; represent department in quality audits; initiate change requests (CR) for Standard Operating Procedures (SOP); ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Seniority
Senior, hands-on IC
