Principal CQV Engineer

Simtra BioPharma Solutions•Bloomington, IN

7d•Onsite

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. We are looking for a Commissioning, Qualification, and Validation (CQV) Principal Engineer responsible for creating and maintaining best practices for Engineering documentation generation and review within the pharmaceutical manufacturing industry, as well as equipment life cycle management. The position works closely with cross-functional teams including quality, EHS, maintenance, and manufacturing, and reports to the Director of Engineering. This position is 100% onsite at the Bloomington, Indiana facility.

Requirements

BS degree in Engineering, Life Sciences, or related technical field
10+ 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

The CQV Principal Engineer partners cross-functionally across Engineering, Maintenance, and Quality to ensure Engineering practices are compliant with procedures and Regulatory guidelines
Serve as subject matter expert (SME) for Commissioning, Qualification, and Validation. Develops and delivers training to Engineers and applicable team members
Authors, reviews, and approves Engineering documentation (protocols, reports, deviations, change controls, and CAPAs related to CQV scope)
Manages team of professionals responsible for Validation Maintenance/Periodic Review program. Facilitates governance and tracks and reports progress, risks, and resource needs to leadership.
Supports regulatory inspections and client audits. Drives and maintains Audit Readiness and leads corrective actions to closure without repeat occurrences
Participates/collaborates with internal departments and external engineering firms in feasibility assessments, concept design, basic design and detail design