Manager, Computer Systems Validation (CSV)

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 seeking a Manager or Sr. Manager, Computer Systems Validation (CSV) to join the Forge Biologics team, a member of Ajinomoto Bio-Pharma Services. The CSV Manager will lead a dynamic team of validation engineers, including contractors, in support of our state-of-the-art gene therapy manufacturing facility in Columbus, Ohio. This role focuses focus on computer systems validation, equipment network integration, data integrity compliance, and CSV program continuous improvement. This individual will play a key role throughout the computer system lifecycle for the assessment of new systems, validation of GxP/GMP systems and changes for existing systems, to ensure that all critical systems remain in a validated state. This is a highly cross-functional role, ensuring that 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

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

Review and approval of computer system validation deliverables throughout the computer system lifecycle, developed in partnership with functional teams, ensuring the documentation meets regulatory requirements and quality standards. Authorship and execution of CSV deliverables, as needed to support projects and company objectives

Maintain validation status of GxP computer systems

Support GMP Manufacturing and QC Laboratory Equipment Commissioning & Qualification (C&Q) with System and Network Integration, and Data Integrity/Part 11 Compliance 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, Q9, Annex 11 and applicable regulations, good engineering practice and industry standard procedures

What You'll Bring

Bachelor’s Degree in Engineering, Computer Science, or a related discipline

Proven experience leading engineering teams (full-time (FTE) and contractors)

Experience working in the Biotechnology, Pharmaceutical, Medical Device or other regulated industry

Hands-on experience with Supervisory Control and Data Acquisition (SCADA) Systems and GMP Network integration (Active Directory, data transfer, etc.) of GMP equipment

Understanding 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

Highly organized, detail-oriented, and self-driven

Excellent communication skills, with the ability to influence and collaborate cross-functionally

Strong project management skills and a demonstrated ability to lead teams and meet deadlines in a dynamic environment

Ability to work onsite in Columbus, Ohio 4 days/week on average

Preferred Skills:

Ability to read and interpret network architecture and data flow diagrams

Working knowledge of Software Development Lifecycle (SDLC) and Computer Software Assurance (CSA) principles

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 tools like Netsuite ERP, Rockwell Factory Talk and Historian Software

Familiarity with various data science and analytics tools (e.g., JMP, Benchling)

Strong troubleshooting skills and experience leading investigations related to computerized systems

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

Competitive Paid Time Off plan

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)

Onsite fitness facility

Professional & Personal development resources