Validation Technician (Cell Therapy CDMO)

JOB SUMMARY

Cellipont Bioservices is growing, and we are looking for a **Validation Technician **who believes in the potential bridging client discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. This is an exciting position with great professional development opportunities with a quickly growing company.

We are seeking for a highly motivated **Validation Technician** to support validation projects for cell therapy manufacturing. The individual in this role will be trained to support validation projects of medium complexity (equipment, utilities, facilities, processes, computerized systems, etc.) in areas such as executing validation approach, qualification studies, documentation generation and review (protocols, risk assessments, etc.), and execution alongside validation contractors.

With support, the **Validation Technician** supports maintaining systems in a validated state through protocol execution, documentation support, and coordination of field activities. Under the direction of Validation Engineers and Management, the **Validation** **Technician** assists with validation of lifecycle activities including protocol execution, documentation generation and review, data analysis support, and ongoing validation maintenance. The ideal candidate demonstrates a strong understanding of cGMP requirements, sound technical judgment, and the ability to adapt to shifting priorities within a fast-paced startup environment.

THE ROLE

• 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
• Execute IQ/OQ/PQ protocols as written and ensure accurate, GDP-compliant documentation
• As required, Assist in drafting validation protocols and reports under supervision
• Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors
• Review validation lifecycle documentation, including requirements, specifications, protocols, and reports
• Support the Validation Team in any required activities to support the development, execution, or improvement of the Validation program
• Understand the application of Data Integrity per 21 CFR Part 11
• Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulations

THE CANDIDATE

• High School Diploma required OR Associate or Bachelor's Degree in a Science or Technical field preferred
• Basic understanding of cGMP principles or direct experience in GMP environment preferred
• Foundational knowledge of equipment qualification concepts (IQ/OQ/PQ) is a plus
• Knowledge of cGMP, GAMP, 21CFR part 11, GDP is a plus
• Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment is a plus
• Strong attention to detail and documentation accuracy
• Ability to follow approved procedures and execute protocols precisely as written
• Effective communication skills and ability to work cross-functionally
• Proficient in Microsoft Office Suite (Word, Excel, Outlook)
• Ability to manage multiple assigned tasks in a structured environment
• Self-motivated with strong organizational skills

Working Conditions:

• May be required to work in controlled or clean room environments
• Must be able to read, write, and converse in English

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling

Environmental Conditions:

• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes
• Ability to work safely and effectively when working alone or working with others

POSITION BENEFITS

• 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 your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space