Senior Equipment Engineer

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.

Essential Duties and Responsibilities

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• 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

Preferred:

• 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

Travel Requirements

• 10% (Low) Travel

Location

• This is a 100% site-based position located at the Durham, NC site. 
•  This position may require some non-standard working hours, including early morning or late evening.

 #LI-Onsite

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.