Cell Therapy Validation Engineer Jobs (NOW HIRING)

Developing and manufacturing your cell therapies from benchtop to bedside

Cellipont Bioservices is growing, and we are looking for a Validation Engineer who believes in the bridge between client discoveries and patient cures and who wants to challenge the status quo to take Cellipont and its clients to the next level.

Will be part of the Validation team and participate in validation initiatives for current and future cell therapy programs, demonstrating the values, culture, and deliverables for the site.

In this role, the Validation Engineer will be trained to support medium‑complexity validation projects (equipment, utilities, facilities, processes, computerized systems, etc.) and will execute validation approaches, qualification studies, documentation generation and review (protocols, risk‑assessments, etc.), and work alongside validation contractors. With support, the engineer will collaborate with contractors and act as a validation signatory representative to review and approve validation lifecycle documentation for GMP use, accountable to management and regulatory agencies. The role will also contribute to establishing and maturing all aspects of the validation program required to maintain the cGMP facility for cell therapy.

• Support GMP validation projects of low to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in‑house and contracted resources
• Oversee qualification activities in cGMP validation best practices
• Develop qualification and validation protocols, execute associated studies, analyze data, and develop final reports
• Support validation deviation investigations and determine assignable causes with the Validation Lead and contractors
• Review validation lifecycle documentation, including requirements, specifications, protocols, and reports
• Support the Validation Team in development, execution, or improvement of the Validation program
• Understand the application of Data Integrity per 21 CFR Part 11
• Apply FDA, GLP, QSR, and cGMP regulations
• Apply equipment qualification principles in a cGMP environment (IQ, OQ, PQ)
• Understand the validation lifecycle in GMP settings
• Apply knowledge of cGMP, GAMP, 21CFR Part 11, GDP
• Apply knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment

• Bachelor's Degree with 1+ years of cGMP experience in the Pharmaceutical or Life Sciences industry; Master’s Degree is a plus
• Experience with the qualification of cell therapy equipment and cGMP environment is a plus
• Excellent interpersonal skills with experience dealing with a diverse workforce
• Strong multitasking and organizational skills in a high‑paced environment
• Ability to organize and monitor tasks concurrently with others to ensure timely completion
• Highly proficient computer skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Quick learner of new technologies
• Creative problem‑solving ability, able to think outside the box
• Self‑motivated and self‑starter, able to work independently with minimal supervision
• Proactive, results oriented, with strong attention to detail
• Strong written and verbal communication skills, including technical writing
• May be required to work in controlled or clean‑room environments
• Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting to 25 lbs
• Ability to sit, stand, walk, and move within the workspace for extended periods
• Ability to perform repetitive tasks, including hand‑to‑finger manipulations, grasping, pushing, and pulling
• Primarily office environment but may require entry into laboratory or GMP process areas with appropriate gowning, lab coats, or PPE such as safety glasses and shoes
• Work safely and effectively alone or with others

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross‑functional exposure to other areas within the organization
• Robust benefit package designed for unique health & wellness needs, including coverage for pets
• 401(k) with strong employer match
• Tuition reimbursement
• Employee referral bonuses
• Flexible work schedules and PTO based on role/level, increasing one PTO day each year, and paid holidays
• Experience in the cutting‑edge cell therapy space