Quality Engineer II

Forge is a gene therapy development engine focused on enabling access to life-changing gene therapies, partnering with innovators in the gene therapy community.
Backend
Mid-Level Software Engineer
Hybrid
101 - 500 Employees
3+ years of experience
Biotech · Healthcare

Description For Quality Engineer II

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is seeking a Quality Engineer II to join their innovative gene therapy development team. This role focuses on quality oversight of validation activities, particularly in Computer Systems, Software, and Data Integrity.

The position offers an opportunity to work with cutting-edge gene therapy manufacturing processes while ensuring compliance with regulatory requirements. You'll be part of a cross-functional team providing technical and quality input, working closely with Quality Management, IT/Automation, and Operations teams.

The company culture is built on their H.O.P.E. values:

  • Hardworking: Making persistent and determined efforts toward success
  • Open: Encouraging open communication and constructive feedback
  • Purpose Driven: Passionate about manufacturing gene therapies
  • Engaged: Fully absorbed in furthering Forge's vision and mission

The role offers comprehensive benefits including excellent health coverage (90% premiums covered), flexible PTO, 401(k) match, and professional development opportunities. Located in Columbus, Ohio, this position requires 4 days/week onsite presence.

This is an excellent opportunity for a quality professional with experience in biotechnology or pharmaceuticals to join a company that's revolutionizing gene therapy manufacturing. You'll play a crucial role in ensuring quality standards while working with state-of-the-art systems and contributing to life-changing medical advances.

Last updated 20 days ago

Responsibilities For Quality Engineer II

  • Quality oversight of Validation activities, with focus on Computer Systems, Software, and Data Integrity
  • Provide quality review & approval of Commissioning, Qualification, and Validation deliverables
  • Support quality review & approval of GMP records
  • Collaborate with system and process owners to define system requirements
  • Provide SME support for change management and quality events
  • Support resolution of issues from internal quality assessments/audits
  • Champion and lead continuous improvement efforts
  • Support internal and external audits

Requirements For Quality Engineer II

Python
  • Bachelor's Degree in Science, Engineering or related discipline
  • Minimum 3 years of experience in quality engineering
  • Experience in Biotechnology, Pharmaceutical, Medical Device or regulated industry
  • Knowledge of Software Development Lifecycle (SDLC) and Computer System Validation (CSV)
  • Experience with SaaS enterprise systems
  • Experience with automation systems
  • Knowledge of cGMP and CFR Part 210, 211 and 820
  • Knowledge of ISPE guidelines
  • Ability to work onsite 4 days/week in Columbus, Ohio

Benefits For Quality Engineer II

401k
Dental Insurance
Medical Insurance
Mental Health Assistance
Parental Leave
Vision Insurance
  • Health, Dental, and Vision insurance (90% premiums covered)
  • Flexible PTO plus 14 paid company holidays
  • Annual bonus for full-time employees
  • 401(k) company match
  • Fully-stocked kitchen with free food/drinks
  • 12 weeks paid parental leave
  • Employee Assistance Program
  • Wellness benefits
  • Professional & Personal development resources

Interested in this job?

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