Senior Manager, Validation Engineering - North Carolina, Durham

The announced job offer is made public by the firm: Resilience and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of North Carolina at the city Durham, in the country US - at this current ZipCode: 27701

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Position Title

Senior Manager, Validation

Hiring Manager

Lee Smith

Franchise/Department

Durham Gene Therapy, Engineering and Facilities

Location

RTP

Contact

Lee Smith

General Company Description

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients' lives.

For more information, visit .

Position Summary & Role

As the validation manager for Resilience, you will have responsibilities for developing and maintaining internal capabilities of the Commissioning, Qualification, Validation (CQV) team.You will lead the implementation and execution of Resilience validation program for internal vector manufacturing and laboratory facilities- at the RTP site. This includes validation and qualification of instrumentation, equipment, utilities, facilities and along withthe requalificationprogram.The candidate willassess validation packages, perform gap analysis to User Requirementsanddevelop plans and protocolsthat comply with company policies and procedures. In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required.You will lead, develop and maintain a team of full time and contract engineers to accomplish these goals.

Job Responsibilities

• Management of the RTP site CQV team, contract, and consultant resources.
• Provide ownership and leadership for the sites commissioning, qualification, validation, and requalification programs.
• Provide oversight for the writing, execution, summarization, for validation activities
• Provide technical inputand lead validation activitiesfor:Analytical instruments, Equipment, Utilities, and Facilities
• Provide oversight for the development of Validation Plans and Validation Plan Summary Reports
• Provide technical input to protocol exceptions to efficiently drive resolution
• Provide oversight for the development and assessment of CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain tovalidation
• Provide technical input to strategy and philosophy forvalidation activities
• Representvalidationduring tech transfer activities
• Front facing during agency inspections representing the validation functionand support audit responses for observations impactingvalidation.
• Lead and manage complex validation and technical projects
• Develop the CQV team to support the equipment for both clinical and commercial manufacturing.
• Participation in budgeting and long-range forecasting for site and process validation program improvements.
• Develop and maintain documents related to SOP's, Work Plans, Job Aids, Various Policies and Procedures, etc.

Preferred Experience, Education & Qualifications

• Minimum ofbachelor'sdegree in science, engineering or related discipline
• Minimum 10years of experience inthe establishment and execution of validation commissioning, qualification, validation, and requalification programsin pharmaceutical/biotech manufacturing environment
• Minimum 7 years leading validation team
• Thorough knowledge and understanding of FDA and international health authority expectations
• Ability to effectively participate in a dynamic work environment consisting of clinical and commercial manufacturing
• Subject MatterExpertisein authoring and review/approval of SOPs
• Superb organizational and communication skills
• A passion for addressing the critical unmet medical needs of patients.

Other Ideal Personal Characteristics:

• Excellent management skills with demonstrated organizational, administrative, interpersonal, communication and supervisory skills with the demonstrated ability to work with a wide variety of people.
• Self-directed individual whocanwork with limited direction in a fast-paced, goal-oriented environment
• Pharmaceutical GMP and GLP expertise