Cellectis
Senior Manager / Associate Director, Validation
Cellectis, Raleigh, North Carolina, United States, 27601
Overview
Senior Manager / Associate Director, Validation role at Cellectis. Leads the Validation group in MSAT and is accountable for Raleigh’s validation program for equipment, facilities and utilities, control and/or data recording systems, and Process Performance Qualification. Ensures validation approaches align with industry standards (cGMPs, GAMP 5, ISPE, ICH) and regulatory guidance including Data Integrity.
Position Responsibilities
Ownership of the lifecycle validation approach for equipment, controlled areas, and clean utilities.
Owns the Raleigh Site Validation Master Plan
Ensures compliance with industry- and agency-recognized norms – cGMPs, GAMP 5, ISPE guidelines, ICH guidelines
Optimizes onboarding and qualification processes and periodic requalification
Manages writing of validation protocols, protocol execution, and summary reports
Ensures CSV SMEs support all equipment owners in meeting GAMP 5 and data integrity for GxP software
Establishes minimal standards for risk assessments of control, automation, and data recording systems and mitigates compliance gaps
Partners with Regulatory, Quality, and MSAT/Process Sciences to design PPQ campaigns for product registration
Establishes phase-appropriate validation concepts for single-use systems, including leachable/extractable evaluations and contracted studies as necessary
Applies technical standards for processing, packaging, and materials; employs QbD, DOE, PAT where applicable
Qualifications
Bachelors or Masters in biological or chemical sciences, Chemical Engineering, Pharmacy, Pharmaceutical Technology, or related field; PhD desirable
8–12 years’ experience in validation, with 2–4 years direct manager experience
Proven success in delivering outstanding results
Strong working knowledge of regulatory standards and guidances on validation in pharma/biopharma, ISPE and PDA
Expert working knowledge of cGMPs and GAMP5
Technical Skills / Core Competencies
Exemplifies teamwork across the organization and manages collaborative efforts
Subject matter expert in facilities/equipment/control systems validation and process validation lifecycle
Demonstrates Cellectis’ values and fosters a positive work environment
Effective in complex or matrixed environments
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Other
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Position Responsibilities
Ownership of the lifecycle validation approach for equipment, controlled areas, and clean utilities.
Owns the Raleigh Site Validation Master Plan
Ensures compliance with industry- and agency-recognized norms – cGMPs, GAMP 5, ISPE guidelines, ICH guidelines
Optimizes onboarding and qualification processes and periodic requalification
Manages writing of validation protocols, protocol execution, and summary reports
Ensures CSV SMEs support all equipment owners in meeting GAMP 5 and data integrity for GxP software
Establishes minimal standards for risk assessments of control, automation, and data recording systems and mitigates compliance gaps
Partners with Regulatory, Quality, and MSAT/Process Sciences to design PPQ campaigns for product registration
Establishes phase-appropriate validation concepts for single-use systems, including leachable/extractable evaluations and contracted studies as necessary
Applies technical standards for processing, packaging, and materials; employs QbD, DOE, PAT where applicable
Qualifications
Bachelors or Masters in biological or chemical sciences, Chemical Engineering, Pharmacy, Pharmaceutical Technology, or related field; PhD desirable
8–12 years’ experience in validation, with 2–4 years direct manager experience
Proven success in delivering outstanding results
Strong working knowledge of regulatory standards and guidances on validation in pharma/biopharma, ISPE and PDA
Expert working knowledge of cGMPs and GAMP5
Technical Skills / Core Competencies
Exemplifies teamwork across the organization and manages collaborative efforts
Subject matter expert in facilities/equipment/control systems validation and process validation lifecycle
Demonstrates Cellectis’ values and fosters a positive work environment
Effective in complex or matrixed environments
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Other
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