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Validation Program Coordinator

Forge Biologics

Forge Biologics

Operations
Columbus, OH, USA
Posted on Tuesday, June 25, 2024

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.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role

We are currently seeking a Validation Program Coordinator to join the Forge Biologics team. In this newly created role, the Validation Program Coordinator will work as part of a cross functional team coordinating validation activities to support projects and routine business.

What You'll Do

  • Lead project and routine business coordination for validation activities, ensuring resources, documentation, and schedules are in alignment across site projects
  • Regularly provide progress updates to project and routine activities, communicating risks and opportunities to management
  • Support continuous improvement of Validation SOPs and associated controlled documents (templates, forms, controlled lists, work instructions, etc.)
  • As necessary, provide review and approval of validation deliverables (impact assessments, requirements specifications, design qualifications, protocols, reports, etc.), ensuring required policies and procedures are followed to support validation programs.

What You'll Bring

  • Bachelor’s degree in Engineering, Science, or related discipline.
  • Validation and Project Management/Coordination experience within an FDA/EU regulated pharmaceutical, biotech, or related industry/manufacturing company
  • Proficiency in Smartsheet, MS Project, PowerPoint, Word, Excel, Outlook, etc.
  • Experience using electronic Quality Management Systems (e.g., Veeva)
  • Experience in Computerized Maintenance Management Systems (e.g., BMRAM)
  • Working knowledge of manufacturing and laboratory systems
  • Ability to communicate with respect to technical or project management issue.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Preferred Skills

  • Knowledge of validation principles across multiple disciplines, which may include Commissioning and Qualification (C&Q), Computer System Validation (CSV), Sterilization, Aseptic Process Simulation (APS), and/or Process Validation (PV/PPQ/CPV).
  • Familiarity with biotech equipment, facility, utility, computer systems, and processes
  • Experience in the application of pre-clinical, clinical, and commercial cGMPs
  • Experience with aseptic processing and clean room standards
  • Cell & Gene Therapy Industry 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 employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits 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.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.

We’ve Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

  • Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
  • 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 - additional discount programs include childcare support & dependent care
  • Employee Assistance Program
  • Wellness benefits (financial planning services, mental health counseling, employer paid disability)
  • Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches