Principal Supplier Quality Engineer

Simtra BioPharma Solutions

1d•Hybrid

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. This role: The Principal Supplier Quality Engineer (SQE) is responsible for ensuring that external suppliers consistently meet Simtra’s quality, compliance, and performance expectations. This role is 100% dedicated to biopharma operations and focuses on supplier oversight, supplier change management, performance trending, and continuous improvement across the supply base. The SQE partners closely with Supply Chain, Quality Assurance, Technical Services, Manufacturing, and other cross‐functional teams to proactively identify risks, drive corrective and preventive actions, and strengthen supplier quality systems in alignment with global pharmaceutical regulations and internal procedures.

Requirements

Bachelor’s degree required, preferably in a Science or Engineering discipline.
3-4 years of experience in Quality, Manufacturing, or Engineering required; Supplier Quality experience strongly preferred.
Biopharmaceutical, pharmaceutical, medical device, combination product, and/or biologics industry experience highly preferred.
Demonstrated experience in root cause analysis, application of quality tools, corrective and preventive action (CAPA) methodologies, and data analysis and reporting.
Strong knowledge of pharmaceutical regulations and international standards, including FDA cGMP, Eudralex, ISO 13485, ISO 9001, and global aseptic manufacturing regulations.
Proven ability to manage quality relationships with key suppliers, including coordination and leadership of on‐site and off‐site supplier quality development activities.
Project management skills, with the ability to manage multiple issues of moderate to high complexity independently with minimal supervision in a fast‐paced environment.
Business acumen, with an understanding of current and emerging industry trends, policies, technologies, and regulatory expectations.
Strong collaboration and teamwork skills, including effective communication, facilitation, and cross‐functional coordination.
Superior written and verbal communication skills, with the ability to clearly convey technical and regulatory requirements.
Willingness and ability to travel 30%–50%, including international travel.
Flexibility for a hybrid work environment (remote and on‐site), with routine visits to Bloomington, IN and/or Halle, Germany as required to support Simtra operations.

Responsibilities

Manage the supplier change notification lifecycle, including evaluation, risk assessment, approval, tracking, and closure.
Perform trend analysis of supplier quality data and proactively identify emerging risks.
Review, analyze, and report supplier trends, including effectiveness and sustainability of corrective actions.
Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues.
Identify, document, and close gaps between Supplier Quality practices and corporate and local procedures, ensuring regulatory and procedural compliance.
Guide and mentor peers in the application of statistically based quality engineering methodologies, including data analysis, interpretation of results, and risk‐based decision making.
Assess existing supplier quality processes and recommend improvements to enhance compliance, efficiency, and robustness.
Support supplier qualification, performance monitoring, and ongoing quality development activities, including on‐site and remote engagements.
Participate in supplier audits, quality reviews, and business reviews as required.
Ensure supplier quality activities comply with cGMP, global pharmacopoeias, and international regulatory expectations.
Prepare and maintain clear, concise, and compliant documentation, metrics, and reports for internal and external stakeholders.