Quality Engineer (CSV/Data Integrity)

About Forge

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

About the Role

We are currently seeking a Quality Engineer (CSV/Data Integrity) to join the Forge Biologics team. The Quality Engineer (QE) will be responsible for quality oversight of Validation activities, with a focus on Computer Systems, Software, and Data Integrity, as well as GMP records and events in Forge quality systems. The QE will work as part of a cross functional team providing technical and quality input to ensure that products and processes meet the appropriate regulatory agency requirements, internal company standards, and current industry best practices. The individual chosen for this position will work in close partnership with all Quality Management, IT/Automation, and Operations and/or external parties to support GMP activities. 

What You'll Do

• Quality oversight of Validation activities, with a focus on Computer Systems, Software, and Data Integrity
• Provide quality review & approval of Commissioning, Qualification, and Validation deliverables for GMP Systems and Processes
• Support quality review & approval of other GMP records in quality systems
• Collaborate with system and process owners, as well as internal and external subject matter experts (Information Technology, Quality Control, Operations, Development, etc.) to define system requirements, risk-based testing, and ensure systems are fit for intended use
• Provide SME support for change management and quality events to ensure impact assessments, plans, and actions are performed in a compliant manner and any regulated systems are maintained in a GMP state
• Support resolution of issues arising from internal quality assessments/audits, client/regulatory inspections, and aid in driving closure of inspection issues
• Support internal and external audits as needed
• Champion and lead continuous improvement efforts including procedures, work instructions, forms, templates, etc.
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with regulatory cGMP’s, GAMP, ICH, and applicable regulations, good engineering practices and industry standard best practices.

What You'll Bring

• Bachelor’s Degree in Science, Engineering or related discipline.
• Minimum 3 years of experience in quality engineering, or related role.
• Experience working in the Biotechnology, Pharmaceutical, Medical Device or other regulated industry.
• Working knowledge of Software Development Lifecycle (SDLC), Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Experience with Software as a Service (SaaS) enterprise systems such as electronic Quality Managements Systems (eQMS), Validation Management, Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS) and Data acquisition/analysis tools.
• Experience with automation systems such as SCADA, DCS, MES, EMS, Asset manager, and BMS systems.
• Working knowledge of current good manufacturing practice (cGMP) and CFR Part 210, 211 and 820.
• Working knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations.
• Ability to work onsite 4 days/week (Columbus, Ohio) on average.

Preferred

• Ability to read and understand engineering drawing documentation such as data and network architecture diagrams
• Experience with programming languages such as Python and R
• Familiarity with various data science and analytics tools
• Demonstrated experience leading troubleshooting efforts and investigations.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are