Quality Engineer Jobs

Company Overview
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.
Job Overview
We are currently seeking a Quality Engineer to join the Forge Biologics team. The QE 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 AAV facility for pre-clinical and commercial viral vector products.
Responsibilities

• Employ Good Document Practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
• Support early-stage process validation activities including Tech Transfer and Quality by Design.
• IQ/OQ/PQ Protocols, as necessary
• Initiate/Update Risk Assessments on systems and processes.
• Provide analytics and statistical process control support to quality and operations.
• 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.
• Perform risk analysis and failure prevention analysis.
• 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)
• 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.
• Review and Approval of Calibration and Preventive maintenance events within a Computerized Maintenance Management System (CMMS)
• Provide support to quality investigations, CAPA’s, Continuous improvement and change controls by providing technical and validation insight and impact assessments.
• Validation Summary Report
• Traceability Matrix (TM)
• Support internal/external audits from a quality engineering and validation perspective.
• Validation Project Plan
• Draft and execute the following validation documentation:
• Requirement Specification (URS)

Requirements

• Experience working in a GMP Environment with Quality Management Systems
• Previous Biologics or Gene Therapy Experience is preferred.
• Contract Manufacturing Experience is preferred.
• 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.
• Bachelor’s Degree in Engineering, Science or equivalent technical background
• Previous Experience with Validation of Equipment, Utilities, etc.