Quality Engineer I

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 I to join the Forge Biologics team. The Quality Engineer will work as part of a cross functional team providing quality oversight, review and approval of engineering, validation, and quality system deliverables to ensure that products and processes meet the appropriate regulatory agency requirements, internal company standards and current industry best practices.  This includes but may not be limited to commissioning and qualification of GMP equipment and facilities, validation of computerized systems, and process performance qualification.  The individual chosen for this position will work in close partnership with all operational departments and/or external parties to support GMP manufacturing of drug products.  The focus of this role is to employ site approaches to ensure Forge provides and maintains a state-of-the-art gene therapy facility for pre-clinical and commercial viral vector and plasmid products.

What You'll Do

• Review and Approval of Calibration and Preventive maintenance events within a Computerized Maintenance Management System (CMMS).
• Review and approval of validation documents across validation disciplines developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards (Commissioning & Qualification, Computer System Validation, Process Performance Qualification, etc.)
• Initiate/Update Risk Assessments on systems and processes.
• Perform risk analysis and failure prevention analysis.
• Support early-stage process validation activities including Tech Transfer and Quality by Design, as necessary. 
• Provide analytics and statistical process control support to quality and operations. 
• Provide support to quality investigations, CAPA’s, Continuous improvement and change controls by providing technical and validation insight and impact assessments. 
• Assist with resolving issues arising from internal quality assessments/audits, future regulatory inspections, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Support internal/external audits from a quality engineering and validation perspective.
• Employ Good Document Practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations, good engineering practice and industry standard procedures.

What You'll Bring

• Bachelor’s Degree in Engineering, Science or equivalent technical background
• Experience working in a GMP Environment with Quality Management Systems
• Working knowledge of cGMPs, ISPE Guidelines, Data Integrity, 21 CFR Part 11 and Annex 11 Regulations, and Industry Good Practices for Installation, Operational, and Performance Qualifications, along with Standard Operating Procedures.
• Must have strong attention to detail, be organized and proactive.
• Strong verbal and written communication skills.
• Ability to meet deadlines and use critical thinking skills to problem-solve effectively.

Preferred

• Previous experience with Commissioning, Qualification, & Validation (CQV) processes
• Previous Biologics or Gene Therapy experience
• Contract Manufacturing experience

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. 

Forge Biologics is an equal opportunity em