Simtra BioPharma Solutions
Biopharma
PrincipalSupplierQualityEngineer
Neural analysis suggests this role is
optimal for Principal candidates.
“Principal Supplier Quality Engineer at Simtra BioPharma Solutions. Skills: Supplier Quality Engineering, Quality Assurance, Regulatory Compliance, Risk Management, Data Analysis. Ensuring that external suppliers consistently meet Simtra’s quality, compliance, and performance expectations.. Supplier oversight, supplier change management, performance trending, and continuous improvement across the supply base.”
What You'll Achieve.
Ensure external suppliers consistently meet Simtra’s quality, compliance, and performance expectations.; Strengthen supplier quality systems in alignment with global pharmaceutical regulations and internal procedures.; Enhance compliance, efficiency, and robustness of supplier quality processes.
Industry & Context.
Proactively identify risks; Drive corrective and preventive actions; Resolve supplier quality issues; Identify, document, and close gaps; Assess existing supplier quality processes and recommend improvements; Root cause analysis; Data analysis; Risk-based decision making
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., May be required to wear personal protective equipment (PPE) such as safety shoes, gowns, gloves, eye protection, and hearing protection during site visits., Duties may require overtime work, including nights and weekends., Role requires sitting for long hours but may involve walking or standing for long periods of time.
What They're Looking For.
Must Have
Bachelor's degree required, preferably in a Science or Engineering discipline., 3-4 years of experience in Quality, Manufacturing, or Engineering, Demonstrated experience in root cause analysis, application of quality tools, corrective and preventive action (CAPA) methodologies, and data analysis and reporting., 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., 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.
Nice to Have
Supplier Quality experience strongly preferred., Biopharmaceutical, pharmaceutical, medical device, combination product, and/or biologics industry experience highly preferred.
What You'll Do.
Ensuring that external suppliers consistently meet Simtra’s quality
and performance expectations.
supplier change management
and continuous improvement across the supply base.
Manage the supplier change notification lifecycle
Perform trend analysis of supplier quality data and proactively identify emerging risks.
and report supplier trends
including effectiveness and sustainability of corrective actions.
and close gaps between Supplier Quality practices and corporate and local procedures
ensuring regulatory and procedural compliance.
Assess existing supplier quality processes and recommend improvements to enhance compliance
Support supplier qualification
performance monitoring
and ongoing quality development activities
including on‐site and remote engagements.
Participate in supplier audits
and business reviews as required.
Ensure supplier quality activities comply with cGMP
global pharmacopoeias
and international regulatory expectations.
Prepare and maintain clear
and compliant documentation
and reports for internal and external stakeholders.
How You'll Work.
Team & Collaboration
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.; Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues.; Guide and mentor peers in the application of statistically based quality engineering methodologies.; Collaboration and teamwork skills, including effective communication, facilitation, and cross‐functional coordination.
Communication Scope
Superior written and verbal communication skills, with the ability to clearly convey technical and regulatory requirements.
Process & Methodology
Project management skills, with the ability to manage multiple issues of moderate to high complexity independently with minimal supervision in a fast‐paced environment.
Full Job Description
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. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. 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
Applying for this Principal Supplier Quality Engineer role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Simtra BioPharma Solutions?
Real rants from real employees. Read before you apply.