Engineering Manager (Compliance)

Simtra BioPharma Solutions - Bloomington, IN

Hiring: Engineering Manager (Compliance) Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-10 13:51:40 Employment Type: Contract Target Skills & Keywords : Pest About the job Experience: •8+ years experience in pharmaceutical/biotech industry preferred Required Skills: •The Engineering Compliance Manager manages a team of professionals responsible for compliance to regulatory and governing documents and practices within the Engineering and Maintenance departments. This position oversees closure of open gaps and drives improvement. This position reports to the Director of Engineering. •The Compliance Manager partners cross-functionally across Engineering, Maintenance, and Quality to drive open E&M owned corrective actions to closure without repeat occurrences. Facilitates governance for CAPA and finding closures. Tracks and reports progress, risks, and resource needs to leadership. •Drives and maintain Audit Readiness; ensure compliance with procedures and maintain facility/site drawings •Manages a team responsible for deviation investigation, corrective actions, and on-time closure for batch release. •Collaborates with vendors and internal personnel to ensure adherence to pest control standards. Responsible for ensuring monthly pest control reports and trending analysis. Analyze trends and implement corresponding facility improvements. •Reporting team facilitates asset creation in ERP system, SOP revision, and engineering documentation review and approval •Ensures compliance to procedures and reviews practices, including logbook reviews and vendor checks •Author, review, and approval protocols, reports, deviation investigations, change controls, and CAPAs related to CQV scope Qualifications: •BS degree in Engineering, Life Sciences, or related technical field Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!