Senior Validation Engineer I

Forge Biologics•Columbus, OH

6d•Onsite

About The Position

We are currently looking for a highly skilled and experienced Senior Validation Engineer I to join the Forge Biologics team. As a Sr. Validation Engineer I, you will be responsible for the design, implementation, and execution of process validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. You will work closely with cross-functional teams to develop and execute validation strategies, provide technical expertise in process validation and aseptic process simulation to ensure adherence to regulatory compliance and industry best practices.

Requirements

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.

Nice To Haves

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.

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.

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.