Validation Technician (Cell Therapy CDMO)

Job Description

Job Description

Bridging Innovation to Cure"Developing and manufacturing your cell therapies from benchtop to bedside"JOB SUMMARYCellipont 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 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 ROLESupport GMP validation projects of low to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resourcesOversee qualification activities in cGMP validation best practicesExecute 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 contractorsReview validation lifecycle documentation, including requirements, specifications, protocols, and reportsSupport the Validation Team in any required activities to support the development, execution, or improvement of the Validation programUnderstand the application of Data Integrity per 21 CFR Part 11Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulationsTHE CANDIDATEHigh School Diploma required OR Associate or Bachelor's Degree in a Science or Technical field preferredBasic understanding of cGMP principles or direct experience in GMP environment preferredFoundational knowledge of equipment qualification concepts (IQ/OQ/PQ) is a plusKnowledge of cGMP, GAMP, 21CFR part 11, GDP is a plusKnowledge of pharmaceutical, manufacturing, and laboratory systems and equipment is a plusStrong attention to detail and documentation accuracyAbility to follow approved procedures and execute protocols precisely as writtenEffective communication skills and ability to work cross- functionallyProficient in Microsoft Office Suite (Word, Excel, Outlook)Ability to manage multiple assigned tasks in a structured environmentSelf-motivated with strong organizational skillsWorking Conditions:May be required to work in controlled or clean room environmentsMust be able to read, write, and converse in EnglishPhysical / 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 periodsAbility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pullingEnvironmental 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 shoesAbility to work safely and effectively when working alone or working with othersPOSITION BENEFITSOpportunities for career growth within an expanding teamDefined career path and annual performance review & feedback processCross-functional exposure to other areas within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members401K strong employer match Tuition ReimbursementEmployee Referral BonusesFlexible 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 "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm RepresentativesCellipont Bioservices does not accept unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral.