Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The “Automation Validation Lead” will be responsible for oversight and hands-on execution of the automation system lifecycle for all GxP-Regulated Automation Computerized Systems, ensuring compliance with regulatory requirements, Automation Computer Systems Validation (ACSV) and Lifecycle procedures with Data Integrity requirements.

Primary Responsibilities:

Oversight and Execution of Automation CSV Activities:

• Provide comprehensive oversight and execution of all automation CSV activities across both Beam NC and Cambridge sites, ensuring compliance with regulatory requirements and internal SOPs.
• Plan, organize and lead the development, execution, and approval of all validation documentation, including:
  • Validation Plans
  • Requirements Specifications
  • System Impact Assessment
  • Installation/Operational/User Acceptance Testing (IQ/OQ/UAT)
  • Traceability Matrices
  • Validation Final Reports
• Work closely with engineering and project teams, Digital Quality, and Product Quality Assurance to determine scope of validation activities.
• Maintain a flexible and proactive approach to supporting the overall success of the Automation CSV and data integrity programs.
• Apply subject matter expertise to evaluate and anticipate problems and recommend compliant solutions.
• Mentor other cross-functional team members on implementation and execution of ACSV projects and programs.

GxP Compliance and Data Integrity:

• Manage product release cycles to ensure all Automation GxP systems across both Beam NC and Cambridge sites maintain continuous compliance.
• Regularly review all GAMP 5 deliverables for accuracy and completeness, providing constructive feedback and ensuring adherence to associated SOPs.
• Collaborate with stakeholders to maintain and update GxP computerized system and ACSV SOPs, reflecting best practices and regulatory changes.
• Conduct periodic reviews of all validated systems to ensure continued compliance with regulations and SOPs.

Change Management:

• Implement and enforce effective change control processes to minimize risks and ensure data integrity.
• Conduct thorough impact assessments of proposed changes to computerized systems, ensuring no negative impact on system integrity or data compliance.

Regulatory and External Audits:

• Serve as a subject matter expert for ACSV, providing support during regulatory and external audits.
• Participate in audit preparation, provide accurate and comprehensive responses to audit inquiries, and address any identified issues promptly and effectively.

Qualifications:

• Degree or certifications in Information Technology, Engineering, or other BS with appliable experience.
• 14+ years’ experience in Automation Computer Systems Validation.
• Detailed knowledge of GxP regulations and ACSV principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
• Strong attention to detail and a commitment to accuracy and compliance.
• Familiarity with validation of automation solutions for products such as DeltaV, OSI PI, Siemens Desigo CC, Cytiva Unicorn, Manufacturing Execution Systems (MES), and with electronic Validation Lifecycle Management tools (e.g Kneat, Veeva).
• Excellent project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively.
• Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders.