What are the responsibilities and job description for the Quality Assurance Engineer position at The Steely Group?
We are seeking a proactive and detail-oriented Quality Assurance Engineer to support our growing Morrisville operations. This role serves as a critical bridge between Engineering and Quality Assurance, providing technical oversight for equipment validation, facility management, and process performance. You will be instrumental in ensuring that our infrastructure and processes are robust, compliant, and ready to support the delivery of the next generation of genetic medicines.
Core Responsibilities
- Validation & Qualification (IQ/OQ/PQ): Lead the QA review and oversight of Installation, Operational, and Performance Qualifications for both manufacturing and analytical equipment (including computerized systems and software) within the Morrisville facility
- Process Validation & Tech Transfer: Provide QA technical support for technology transfer activities and Process Performance Qualification (PPQ), ensuring the seamless integration of new processes into production
- Facility & Engineering Oversight: Review and approve facility-related documentation, including work orders, asset management records, and engineering change controls to maintain site-wide compliance
- Deviations & CAPA Management: Serve as the primary Quality contact for investigations and deviations related to facility and engineering issues; drive robust root-cause analysis and implement effective CAPAs
- Document & Procedure Management: Author, review, and update Standard Operating Procedures (SOPs) and technical processes to enhance site compliance and operational efficiency
- Risk Management: Facilitate and support quality risk management activities (e.g., FMEA) to proactively identify and mitigate risks to product quality or facility operations
- Operational Support: Support broader Quality Assurance Operations initiatives and cross-functional projects as needed
Requirements
- Education: B.S. in Engineering, Life Sciences, or a related technical discipline
- Experience: 5 years of experience in Quality Assurance Engineering, Validation, or Technical Quality within the Biopharmaceutical or Biotech industry
- Technical Knowledge: Comprehensive understanding of cGMP, GAMP 5, and the validation lifecycle. Experience in Gene Therapy, advanced therapies (ATMPs), or sterile manufacturing environments is a significant plus
- Agility & Impact: Ability to thrive in a high-growth site environment, effectively balancing the agility of a clinical-stage company with the rigor of global quality standards
- Collaboration & Communication: Strong interpersonal skills with a proven track record of partnering successfully across Engineering, Manufacturing, and Quality teams