Senior Equipment Engineer

Kincell Bio, LLC•Durham, NC

4d•Onsite

About The Position

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at www.kincellbio.com. Kincell is seeking a highly motivated Senior Equipment Engineer who will be a key contributor to a dynamic and collaborative Engineering team. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. The Senior Equipment Engineer will work closely with their fellow Engineering team members, the Validation Manager, Manufacturing, Supply Chain, Quality Assurance, R&D, Product Development, Analytical Development and the QC laboratory. The Equipment Engineer will own the full lifecycle of GMP equipment within a fast-paced CDMO startup environment (~100 employees). This role supports rapid onboarding, qualification, and maintenance of equipment while ensuring compliance and enabling scalable manufacturing operations.

Requirements

Validation knowledge/experience
Calibration / Metrology knowledge / experience
Analytical and problem-solving skills required
Must have excellent communication skills and ability to work in a team-oriented environment
Hands-on contributor capable of managing the validation effort and calibration program as well as requirements in the regulated industry
The individual must be capable of independent work
Business setting and acumen
Flexible, proficient in technical writing, and strong interpersonal and communication skills
Required: minimum of 3 years’ experience in a GxP environment working with validation, engineering and calibration
Bachelor’s degree in engineering science/engineering discipline or equivalent

Nice To Haves

Preferred: 3 - 8+ years’ experience in a GxP environment working with validation, engineering, process engineering and facilities
Graduate degree in Engineering Science/Engineering discipline
An equivalent combination of education and experience may be considered

Responsibilities

Lead onboarding of new GMP equipment (URS → FAT/SAT → installation → release)
Responsible for overall asset management and lifecycle of assets. This will include managing the induction of assets, validation of assets, calibration program oversight and overall lifecycle management.
Manage induction and oversight of critical calibration systems (CMMS), this includes initial and ongoing calibration coordination and control.
Coordinate installation, engineering start-up, and validation activities of new equipment and systems including ability to draft and manage documentation of user requirement specifications, system impact assessments, IQ/OQ protocols, execution, and summary reports.
Manage small to large projects and tracking spending, budgets, creating scope of work, risk assessments, justification, cost estimates, implementing purchase order requisitions, and contracts.
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable regulations, and industry codes.
Assist or manage implementation and oversight of critical computerized environmental monitoring systems.
Understanding of asset management, facilities and equipment maintenance and calibration systems is required.
Represent department in Project Team meetings, interact with project teams and cross-functional groups.
Oversight of vendor contact for third party maintenance and calibration activities.