Equipment Validation Specialist

2 weeks ago

Columbus, Ohio, United States Forge Biologics Full time
Job Overview

About Forge Biologics

Forge Biologics is a pioneering entity in the field of gene therapy, dedicated to transforming innovative concepts into viable treatments. We collaborate with a diverse range of stakeholders, including researchers, healthcare professionals, and pharmaceutical companies, to facilitate the development and manufacturing of groundbreaking gene therapies. Our mission is to ensure that these vital therapies reach patients in need, emphasizing a patient-centric approach in all our endeavors.

Position Summary

We are seeking a proficient and knowledgeable Validation Engineer to enhance our Forge Biologics team. In this role, you will take charge of the design, execution, and management of validation processes for our manufacturing equipment, ensuring compliance with quality standards and regulatory requirements. Your collaboration with various teams will be crucial in formulating and implementing effective validation strategies.

Key Responsibilities

  • Formulate and implement validation protocols for equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Review and endorse Commissioning & Qualification (C&Q) documentation, such as User Requirement Specifications (URS) and Design Qualifications (DQ).
  • Establish acceptance criteria and devise testing methodologies for equipment validation, aligning with industry regulations and best practices.
  • Work in conjunction with teams across Process Development, Manufacturing, Quality, and Engineering to ensure the successful execution of validation activities.
  • Lead investigations into validation-related discrepancies and implement corrective actions as necessary.
  • Conduct hands-on validation tasks, including protocol development, execution, data analysis, and reporting, ensuring adherence to internal and external quality standards.
  • Stay informed about industry trends and regulatory changes, proposing enhancements to validation processes.
  • Provide mentorship and technical support to team members, fostering a collaborative and knowledge-sharing environment.

Qualifications

  • Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.
  • Extensive experience in equipment validation within the biotech or pharmaceutical sectors.
  • Familiarity with a variety of equipment, including Isolators, Filling & Capping machinery, Biological Safety Cabinets, and bioreactors.
  • Knowledge of aseptic processing and cleanroom protocols.
  • Strong analytical and problem-solving capabilities, with a keen attention to detail.
  • Excellent communication skills, with the ability to work effectively across various teams.
  • Proven project management skills, capable of handling multiple validation projects simultaneously.

Preferred Qualifications

  • Experience in the Cell & Gene Therapy sector.
  • Understanding of validation principles across various disciplines, including computerized systems and process validation.
  • Experience with cGMPs in pre-clinical, clinical, and commercial settings.

This job description is intended to provide a general overview of the role and is not exhaustive of all responsibilities and duties.

Life at Forge Biologics

Our team is composed of diverse and passionate individuals committed to redefining the landscape of gene therapy manufacturing. We value creativity and innovation, striving to meet the evolving needs of the industry while adhering to our core values of Hardworking, Open, Purpose Driven, and Engaged.

Benefits

  • Comprehensive health, dental, and vision insurance from day one.
  • Flexible paid time off and paid company holidays.
  • Annual bonuses for all full-time employees.
  • 401(K) with company matching.
  • Access to wellness programs and professional development resources.

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