Job Description

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.

For more information, visit our website at www.kincellis.com.

Kincell is seeking a highly motivated Senior Technician who will be a key contributor to a dynamic and collaborative Facilities and Engineering team.

The Senior Technician will be responsible for general maintenance of the facilities, preventive and corrective maintenance of the supporting infrastructure and equipment at the Kincell Bio facilities in Durham, NC. The role will require day-to-day activities to ensure the site remains active and in good repair.

Essential Duties and Responsibilities

Reasonable accommodations 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.

• The senior technician will assist in providing a clean, controlled environment for production.
• Perform and document preventative and corrective maintenance for manufacturing, lab, and facility equipment.
• Perform and document preventative and corrective maintenance for infrastructure and supporting equipment.
• Perform and document calibrations for manufacturing, lab and facilities equipment.
• Perform accurate, relevant documentation of all work performed in CMMS.
• Keep all work areas clean and orderly.
• Assist in the relocation of furniture, equipment, and staff.
• Provide input to management for the improvement of processes, maintenance activities, and procedures.
• Supervise, escort, and document activities performed by contractors and/or outside vendors.
• Ability to manage unplanned events, coordination of repair, and overall ownership of ensuring the equipment and/or facility is operational.
• This is a key position in the readiness of the instrumentation, equipment, and facilities for any new areas of a Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.
• Attends and actively participates in cross functional meetings to ensure ENG site- and company-wide deliverables are met.
• Normal working hours, may include some overtime.

Qualifications

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

• Minimum of 5 years' experience performing operations and maintenance on utility systems, HVAC systems and/or manufacturing equipment in a CGMP Biotech/Pharmaceutical manufacturing environment.
• Proficiency in LOTO is required.
• Required to be agile and able to pivot priorities with short notice.
• Experience reading control schematics, loop diagrams, and P&IDs.
• Proficient computer skills utilizing MS Office suite applications, Building.

Management Systems, Distributed Control Systems (DCS) and Computerized

• Use and management of maintenance activities within Computerized Maintenance Management System (CMMS).
• Licensure any of the following areas preferred: Refrigeration/HVAC , Electrical.
• Subject matter expert in one or more of the following: Electrical, HVAC, Cleanroom design / maintenance, Regulated Utilities, Building Automation, construction/structural, Gas Distribution, CCA, CAPEX projects, life safety
• Ability to train junior technicians in a 1-1 setting in their trade specialty if needed.
• Knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products as they pertain to maintenance and calibration is beneficial but not required.

Required:

• Proficient written and verbal communication skills and ability to work in a team-oriented environment.
• Demonstrated critical thinking skills and ability to work in a fast-paced environment.
• A strong individual contributor who possesses initiative and drive with pride in their work
• Will need to demonstrate the ability to make informed decisions and be accountable for them.
• Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.
• Must have very good computer system skills, utilizing Outlook, Excel, Word proficiently
• Hands-on contributor capable of understanding the maintenance and calibration programs as well as requirements in the regulated industry.
• The individual must be capable of independent work within a clean room environment.
• Flexible, strong interpersonal and communication skills
• High School Diploma/GED. An equivalent combination of education and experience may be considered.

Preferred:

• Associate degree in maintenance, engineering or a related discipline with a minimum of 3 years of overall experience in facilities maintenance activities
• Bachelor's degree in maintenance, engineering or a related discipline with a minimum of 2 years of overall experience in facilities maintenance activities
• Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Biotechnology, Pharmaceutical, Medical Device Utilities Process.
• An equivalent combination of education and/or experience may be considered.

Travel Requirements

• <10%

Location

• This position is 100% on-site in Durham, NC.
• This position may require some non-standard working hours, including early morning or late evening or weekends.

#LI-Onsite

Kincellis Advanced Therapies 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. Kincellis Advanced Therapies 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: Kincellis Advanced Therapies 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.