Validation Technician (Cell Therapy CDMO)

Cellipont Bioservices • The Woodlands, TX

6d • Onsite

About The Position

Cellipont Bioservices is seeking a highly motivated Validation Technician to support validation projects for cell therapy manufacturing. This role involves supporting validation projects of medium complexity, including equipment, utilities, facilities, and processes. The individual will be trained to execute validation approaches, conduct qualification studies, generate and review documentation such as protocols and risk assessments, and work alongside validation contractors. The Validation Technician will also assist in maintaining systems in a validated state through protocol execution, documentation support, and coordination of field activities. Under the guidance of Validation Engineers and Management, this role supports validation lifecycle activities, including protocol execution, documentation generation and review, data analysis support, and ongoing validation maintenance. The ideal candidate possesses a strong understanding of cGMP requirements, sound technical judgment, and adaptability in a fast-paced startup environment.

Requirements

• High School Diploma required.
• 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.
• Must be able to read, write, and converse in English.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

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.
• Paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED