Engineering Manager (Compliance)

Simtra BioPharma Solutions•Bloomington, IN

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. The Role: 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.

Requirements

BS degree in Engineering, Life Sciences, or related technical field
8+ years experience in pharmaceutical/biotech industry preferred
Excellent oral and written communication skills with the ability to influence cross-functional teams
Strong organizational, planning, and project tracking skills
Ability to manage multiple priorities in a fast-paced environment

Responsibilities

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.
Support regulatory inspections and client audits.
Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.