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Sr Computer System Validation (CSV) Engineer

Forge Biologics

Forge Biologics

Columbus, OH, USA
Posted on Wednesday, April 17, 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 Sr Computer Systems Validation (CSV) Engineer to join the Forge Biologics team, a member of Ajinomoto Bio-Pharma Services. The CSV Engineer will be responsible for determining system criticality, defining validation requirements, developing systems validation documentation, generating, and executing test protocols, and summarizing validation activities in reports. This individual will play a key role throughout the software development life cycle (SDLC) for the validation of new systems and changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of Forges applications and GMP equipment. Forge provides and maintains a state-of-the-art multi-purpose gene therapy facility for pre-clinical and commercial product manufacturing and testing.

What You’ll Do

  • Authorship, execution, review, and approval of computer system validation deliverables throughout the software development lifecycle (SDLC), developed in partnership with functional teams, ensuring the documentation meets regulatory requirements and quality standards.
  • Collaborate with project team members, including Technical Services, Operations, IT/Automation, Development, Quality, and others to define needs and achievable solutions and/or justifications to system requirements. Translate system requirement specifications into executable validation plans and protocols.
  • Maintain validation status of GxP computer systems
  • Draft and execute validation deliverables such as
    • Intended Use (IU)
    • Requirement Specification (URS and FRS)
    • Requirement Risk Assessments (RRA)
    • System Design and Configuration specifications
    • Validation Project Plan
    • User acceptance testing (UAT)/Performance Qualification (PQ)
    • Traceability Matrix (TM)
    • Validation Summary Report
    • Data Integrity/Part 11 testing
  • Support GMP Manufacturing and Laboratory Equipment Software Validation and System Integration efforts
  • Provide support in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state
  • Support to quality investigations, continuous improvements, and change controls by providing technical and validation assessments
  • Support internal and external audits as CSV Subject Matter Expert (SME)
  • Lead continuous improvement of CSV procedures and processes
  • Demonstrate technical expertise to define approaches and execution of computer system validation activities in accordance with cGMP, GAMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q9, Annex 11 and applicable regulations, good engineering practice and industry standard procedures.

What You’ll Bring

  • Bachelor’s Degree in Engineering or related discipline
  • Experience working in the Biotechnology, Pharmaceutical, Medical Device or other regulated industry.
  • Experience with Supervisory Control and Data Acquisition (SCADA) Systems and GMP Network integration (Active Directory, data transfer, etc.) of GMP Equipment
  • Working knowledge of current good manufacturing practice (cGMP) CFR Parts 210 and 211
  • Working knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 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 lead projects, meet deadlines, and use critical thinking skills to problem-solve effectively.

Preferred Skills

  • Ability to read and understand network architecture and data flow diagrams
  • Working knowledge of Software Development Lifecycle and Software Quality Assurance
  • Experience with Software as a Service (SaaS) enterprise systems such as electronic quality managements systems (eQMS), Enterprise Resource planning (ERP), Laboratory Information Management Systems (LIMS) and Supervisory Control and Data Acquisition (SCADA), Building Management Systems (BMS) and analysis tools
  • Familiarity with Netsuite ERP, Rockwell Factory Talk and Historian Software
  • Familiarity with various data science and analytics tools (e.g., JMP, Benchling)
  • Demonstrated experience leading troubleshooting efforts and investigations

Work Environment and Physical Demands

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