Forge Biologics · 4 hours ago
Senior Validation Engineer I
Columbus, Ohio
Full-time
Onsite
Senior LevelForge Biologics is dedicated to enabling access to life-changing gene therapies. The Senior Validation Engineer I will be responsible for the design, implementation, and execution of process validation activities to ensure compliance and quality in manufacturing processes, collaborating closely with cross-functional teams.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs, including development of related procedures, templates, work instructions, and associated documentation
Develop and lead execution of Process Performance Qualification (PPQ) protocols, for GMP manufacturing processes
Maintain and provide continuous improvement of the Aseptic Process Simulation (APS) (Media Fill) program
Develop and lead execution of new aseptic (APS) protocols, for aseptic manufacturing processes
Collaborate with cross-functional teams, including Process & Analytical Development, GMP Manufacturing, Operations , Manufacturing Science and Technology (MSAT), Quality Management, Quality Control, and Regulatory Affairs to ensure effective planning, execution, and completion of validation activities
Define sampling plans and, test methods, and acceptance criteria for validation deliverables, ensuring alignment with regulatory guidelines (FDA, EMA, etc.), industry best practices, and internal procedures
Lead and participate in investigations related to validation deviations, implementing appropriate corrective and preventive actions (CAPAs) as needed
Assess changes to proposed process changes and develop validation plans, as necessary
Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing
Collaborate on risk management, process development studies, technology transfer, and other process validation related activities
Stay abreast of industry trends, regulatory updates, and technological advancements related to process validation in the cell and gene therapy field and propose continuous improvement initiatives to enhance validation processes and practices
Provide technical guidance and mentorship to junior team members, fostering a culture of knowledge sharing and professional development
Support Equipment, Facility, and Utility Commissioning and Qualification efforts, as necessary
Qualification
Required
Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience)
Knowledge of validation principles across multiple disciplines, which may include process validation, aseptic process simulation, equipment qualification, and/or computer systems
Significant experience in process validation within the pharmaceutical or biotechnology industry
Strong understanding of Quality by Design (QbD) principles with proficiency in risk assessment methodologies (e.g., PFMEA) and statistical analysis tools for validation data (e.g., Minitab, JMP)
Strong understanding of cGMPs (current Good Manufacturing Practices)
Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail
Effective communication and collaboration abilities, with the capacity to work cross-functionally and influence stakeholders at various levels of the organization
Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently
Experience in the application of commercial cGMPs
Experience with aseptic processing and clean room standards
Ability to work onsite (Columbus, Ohio) 4-5 days/week on average
Preferred
Process Validation experience in the Cell & Gene Therapy Industry
Experience in qualifying a wide range of equipment, including Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, centrifuges, and analytical instruments
Experience in the application of pre-clinical and clinical cGMPs
Experience with Cleaning Validation
Benefits
Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
Company
Forge Biologics
Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.
Founded in 2020
201-500 employees
H1B Sponsorship
Forge Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$330MKey Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant
Leadership Team
Timothy J. Miller, Ph.D. (he/him)
Cofounder, President & CEO
Erandi De Silva, PhD
Co-founder, Senior Vice President of Product Development
Recent News
2025-12-24
Company data provided by crunchbase