Senior Engineer for Computer Systems Validation

1 week ago

Columbus, Ohio, United States Forge Biologics Full time
About Forge Biologics

Forge Biologics, part of Ajinomoto Bio-Pharma Services, is a pioneering force in gene therapy development, dedicated to facilitating access to transformative gene therapies and assisting in their journey from concept to reality. We collaborate with leaders in the gene therapy sector, including researchers, healthcare professionals, biotech and pharmaceutical firms, and patient advocacy groups. Our expertise in gene therapy manufacturing and therapeutic development empowers teams to navigate the complex path from laboratory to patient care. Our mission is straightforward yet crucial for patients facing health challenges, and we approach it with utmost seriousness. With a focus on patient needs, we are innovating collaborative models to expedite the delivery of these groundbreaking treatments to those in need.

Our headquarters is located in a state-of-the-art facility designed specifically for AAV manufacturing, encompassing 200,000 square feet of dedicated space known as the Hearth. This facility provides comprehensive, scalable manufacturing services.

About the Position

We are in search of a Senior Computer Systems Validation (CSV) Engineer to become a vital member of the Forge Biologics team. The CSV Engineer will take charge of assessing system criticality, establishing validation criteria, crafting validation documentation, and executing test protocols while summarizing validation efforts in comprehensive reports. This role is essential throughout the software development life cycle (SDLC) for validating new systems and modifications to existing systems, ensuring that all critical systems maintain their validated status. The focus will be on computerized systems that support Forge's applications and GMP equipment.

Key Responsibilities
  • Develop, execute, review, and approve computer system validation documentation throughout the SDLC, collaborating with various functional teams to ensure compliance with regulatory standards and quality expectations.
  • Engage with project team members from Technical Services, Operations, IT/Automation, Development, Quality, and other departments to identify needs and feasible solutions or justifications for system requirements. Transform system requirement specifications into actionable validation plans and protocols.
  • Ensure the validation status of GxP computer systems is maintained.
  • Create and implement validation deliverables, including:
    • 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 validation efforts for GMP Manufacturing and Laboratory Equipment Software Integration.
  • Assist in change control processes to ensure technical and documentation impact assessments are conducted in a compliant manner, maintaining regulated systems in a validated state.
  • Contribute to quality investigations, continuous improvement initiatives, and change controls by providing technical and validation insights.
  • Act as a CSV Subject Matter Expert (SME) during internal and external audits.
  • Lead ongoing enhancements of CSV procedures and practices.
  • Exhibit technical proficiency to define and execute computer system validation activities in alignment with cGMP, GAMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q9, Annex 11, and other relevant regulations, as well as industry best practices.
Qualifications
  • Bachelor's Degree in Engineering or a related field.
  • Experience in the Biotechnology, Pharmaceutical, Medical Device, or other regulated industries.
  • Familiarity with Supervisory Control and Data Acquisition (SCADA) Systems and GMP Network integration.
  • Understanding of current good manufacturing practices (cGMP) as per CFR Parts 210 and 211.
  • Knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines, including GAMP 5, FDA Data Integrity guidelines, and 21 CFR Part 11.
  • Strong attention to detail, organizational skills, and a proactive approach.
  • Excellent verbal and written communication abilities.
  • Capability to lead projects, adhere to deadlines, and apply critical thinking for effective problem-solving.
Preferred Qualifications
  • Ability to interpret network architecture and data flow diagrams.
  • Understanding of Software Development Lifecycle and Software Quality Assurance.
  • Experience with Software as a Service (SaaS) enterprise systems such as electronic quality management systems (eQMS), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and SCADA.
  • Familiarity with various data science and analytics tools.
  • Proven experience in leading troubleshooting and investigative efforts.
Work Environment and Physical Demands

This job description is intended to provide a general overview of the responsibilities and requirements of the position. Duties and responsibilities may evolve or new ones may be assigned as necessary.

Forge Biologics is committed to fostering an inclusive and diverse workforce. We provide equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind based on 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 applicable laws.

Life at Forge

Our team is composed of diverse, motivated, and passionate individuals collaborating to redefine how we develop medicines for genetic diseases. We leverage our creativity and expertise to devise innovative solutions, meet emerging demands, and deliver the highest quality services in the industry. Our core values embody H.O.P.E., providing a shared purpose that guides our actions and decisions.

HARDWORKING - We are dedicated and diligent, striving for success through focused effort.

OPEN - We promote an environment of approachability, active listening, and constructive feedback.

PURPOSE DRIVEN - We are committed to our mission of manufacturing gene therapies.

ENGAGED - We are enthusiastic about our work and take proactive steps to advance Forge's vision and goals.

Benefits

We prioritize the health and well-being of our employees, continuously exploring new ways to enhance our benefits package, which includes:
  • Comprehensive Health, Dental, and Vision insurance from day one, with a significant portion of premiums covered.
  • Flexible Paid Time Off (PTO) alongside 14 paid company holidays.
  • Annual bonuses for all full-time employees.
  • 401(K) company matching.
  • A fully-stocked kitchen with complimentary food and beverages.
  • 12 weeks of paid parental leave, along with additional childcare support programs.
  • Employee Assistance Program.
  • Wellness benefits, including financial planning services and mental health counseling.
  • Resources for professional and personal development, including training and mentoring opportunities.

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