Validation Manager, Engineering

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.

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Kincell is seeking a highly motivated Validation Manager 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.

This role will manage the day-to-day activities of the Validation process at multiple sites.  Conduct validation assessments of equipment, facilities and process systems.  Make recommendations for changes and/or improvements and approves appropriate change control documentation.  Draft validation documentation as needed; this role will be a "working manager" role and will require the applicant to supplement activities for Validation.  Ensures appropriate validation documentation is maintained and filed appropriately.  Act as Validation representative in client and regulatory audits. 

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.

• Manage day-to-day activities of the validation group including support engineers
• Ensures proper validation support to multiple facilities
• Define areas of improvement
• Deliver strategic improvements to current systems
• Provide insight for capital expenditures to maintain quality/validation systems if needed.
• Manage Primary Validation Initiatives
• Manage Equipment and Instrumentation Qualification Risk Assessment program
• Manage User Requirements program
• Manage System Impact Assessment program
• Manage Facility and Utility Qualification program
• Manage Manufacturing Process Validation program
• Manage Computer Validation program
• Initiate and Manage Equipment/computerized system review program
• Manage Validation Document Filing and storage system
• Manage validation activities in audits
• GMP Decision Making Authority: Has authority to assign validation strategy/assessment for compliance/GMP capability. Approval authority for procedures, protocols, reports and change controls.

Qualifications

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

Required:

• Associate's degree with a minimum of 5 years in pharmaceutical industry (Validation, Process Development, Technology Transfer, Operations, Quality Assurance)
• Previous work experience should include exposure to a broad range of Pharmaceutical Validation activities such as document control, information technology, GMP Compliance, Risk assessment, Computerized System Supplier Assessment, validation, GAMP, change control, etc.
• Experience in leading and/or managing validation activities a must. 
• An equivalent combination of education and experience may be considered.

Preferred:

• Bachelor's degree preferred, 7-10 years in pharmaceutical industry, preferably cell therapy

Travel Requirements

• 10-25% Travel (multiple sites)

Location

• This is a 100% site-based position located at the Durham, NC site with responsibilities for both the Durham, NC site and the Gainesville, FL operations. 
• 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.