Gene Therapy Manufacturing Specialist

3 weeks ago

Columbus, Ohio, United States Forge Biologics Full time
Job Overview
We are seeking a highly skilled Quality Engineer I to join our team at Forge Biologics. As a Quality Engineer, you will play a crucial role in ensuring the quality of our gene therapy products by providing quality oversight, review, and approval of engineering, validation, and quality system deliverables. This includes commissioning and qualification of GMP equipment and facilities, validation of computerized systems, and process performance qualification.

Responsibilities
  • Review and approve calibration and preventive maintenance events within a Computerized Maintenance Management System (CMMS).
  • Review and approve validation documents across validation disciplines developed by functional validation teams, ensuring documentation meets regulatory requirements and quality standards.
  • 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.
  • Provide analytics and statistical process control support to quality and operations.
  • Support quality investigations, CAPAs, 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.
  • Support internal/external audits from a quality engineering and validation perspective.

Requirements
  • 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.
  • 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.

About Us
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Benefits
  • Estimated salary: $85,000 - $110,000 per year.
  • Health, dental, and vision insurance that starts on your first day at Forge.
  • Flexible PTO (plus 14 paid company holidays).
  • Annual bonus for all full-time employees.
  • 401(K) company match.
  • Fully-stocked kitchen with free food/drinks.
  • 12 weeks of paid parental leave.
  • Employee Assistance Program.
  • Wellness benefits.

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