Validation Strategy Lead – Process & Cleaning

Regulatory Toolkit; Cambridge (MA); In loco; USD 130.000 - 190.000; Tempo pieno

Descrizione del lavoro

Beam Therapeutics in Cambridge, MA is seeking an experienced Manager / Senior Manager, Process and Cleaning Validation to lead validation programs across development and manufacturing. You will design validation studies, supervise master plans, and partner with Process Development, Analytical Development, Manufacturing and Quality to ensure compliant, efficient validation activities.

This role requires 6+ years in biopharma, strong technical writing, and proven project management with

Competenze

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
• Typically 6+ years in biopharma in validation, process engineering, or manufacturing support.
• Experience with quality risk management tools and methodologies.
• Technical writing and documentation skills.
• Project management and communication abilities.
• Experience leading a cross-functional project team.
• Experience with managing direct reports.

Mansioni

• Design and implement validation studies with input from multiple partners.
• Lead development and execution of validation master plans and reports.
• Conduct risk assessments and gap analyses of validation programs.
• Evaluate equipment design and procedures for PQ acceptance criteria.
• Support regulatory submissions and inspection prep for validation findings.
• Train client personnel on validation principles and practices.
• Author, review and approve validation documentation for cGMP.
• Provide leadership in Stage 2 processes for internal/external manufacturing.
• Escalate issues within management lines and governance structures.
• Manage 3–5 direct reports (including contract support).

Conoscenze

Process validation

Project management

Technical writing

Cross-functional leadership

Formazione

Bachelor's degree in Engineering

Strumenti

Smartsheets

Descrizione del lavoro

Beam Therapeutics in Cambridge, MA is seeking an experienced Manager / Senior Manager, Process and Cleaning Validation to lead validation programs across development and manufacturing. You will design validation studies, supervise master plans, and partner with Process Development, Analytical Development, Manufacturing and Quality to ensure compliant, efficient validation activities.

This role requires 6+ years in biopharma, strong technical writing, and proven project management with