Capital Associated Industries, Inc.
  • Raleigh, NC, USA
  • Full Time

THE COMPANY

Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies to target and eradicate cancer cells. Cellectis utilizes gene-edited T-cells (UCART) to create cost-effective "off-the shelf" products from healthy donors that can be immediately made available to patients across all geographies.

By capitalizing on its 19 years of expertise in gene editing built on its flagship trademark technology and pioneering electroporation system, Cellectis uses the power of the immune system. Using its life-science-focused, pioneering genome engineering technologies, Cellectis' goal is to create innovative products in multiple fields and with various target markets.

Cellectis is on an incredible journey and we are looking for passionate individuals to join us on this important mission.

POSITION SUMMARY

The Validation Manager provides expertise, guidance and leadership for the validation strategy and efforts of Cellectis US manufacturing start-up operations. The primary responsibility of this role is to develop, execute and sustain a facility, process, aseptic, shipping, equipment and utilities validation system and site Validation Master Plan. The Validation Manager is responsible for ensuring compliance with company validation guidelines, FDA regulatory requirements and CGMP regulations across site facility, equipment, processes, and support systems.

POSITION RESPONSIBILITIES

  • Designs, implements and manages validation system and activities related to site start-up, commissioning, qualification and validation for GMP manufacturing facility, operations, equipment, utilities, etc.
  • Responsible for authoring, executing and driving site Validation Master Plan.
  • Responsible for site wide compliance with company validation system, FDA regulatory requirements and CGMP regulations.
  • Provides technical expertise and guidance on validation policies/procedures and implementation within manufacturing operations, engineering and quality functional areas.
  • Collaborates with project teams to support commissioning efforts and provide technical input as needed.
  • Evaluates and analyzes validation data for accuracy and sufficiency.
  • Authors, reviews and approves validation project documentation, as appropriate, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, IQ/OQ/PQ Protocols and Summary Reports.
  • Authors, executes and updates developing departmental standard operating procedures (SOPs) and qualification programs to ensure compliance and good practices.
  • Develops and maintains requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and regulatory requirements.
  • Responsible for auditing/monitoring programs for validation system and assists other areas during inspections and audits.
  • Performs environmental mapping and other miscellaneous validation activities
  • Manages validation staff including: hiring, coaching, employee development, and appraising job results.
  • Participates in continuous improvement efforts through evaluation of system trends, performance indicators, audits, management feedback and corrective/preventative actions.
  • Prepares presentations/reports for management regarding the validation status at Cellectis US operations.
  • Stays well-informed of current regulatory and industry developments and standards.
  • Other duties as assigned by management.

 

 

 

 

 

POSITION REQUIREMENTS

  • Bachelor's degree in Science or Engineering or relevant field.
  • Minimum 10 years' applicable experience in validation, QA or facilities engineering in Biotech/Pharma CGMP manufacturing environment required.
  • Extensive knowledge of industry guideline including CGMP, validations/qualifications, regulatory guidelines (i.e.: FDA, EU, ICH, ISO), internal auditing, handling of regulatory inspections.
  • Experience in validation of aseptic processes using single use/disposable systems in Grade A production areas and/or isolation technology.
  • Demonstrated ability to design, execute and analyze manufacturing process validation studies.
  • Demonstrated ability to analyze, investigate and propose approaches to technical and regulatory issues.
  • Technical writing background; able to read/analyze/interpret common scientific/technical documents.
  • Solid judgment and decision making in complex situations.
  • Experience with using validation equipment: Kaye, Veriteq, TCs, Dataloggers, etc.
  • Highly ethical and transparent, with professional sensitivity and care for confidentiality.
  • Project management experience preferred.
  • Excellent written and verbal communications with ability to influence effectively at all levels within organization. Presentations skills required.
  • Excellent MS Office (Word, Microsoft Excel, and Power Point) required.
Capital Associated Industries, Inc.
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