Position Overview:

We are seeking an experienced Process and Cleaning Validation subject matter experts to provide Validation support and leadership for development of the process and cleaning validation programs, strategies to be applied to early processes entering these validation programs, and expertise in validation project management and technical document preparation as needed.

Key Responsibilities:

• Design and implement approaches for validation studies, using knowledge and input from Process Development, Analytical Development, Manufacturing, MST/ENG, and Quality partners.
• Lead the development and execution validation master plans and/or project plans, protocols, and reports for process validation activities.
• Conduct risk assessments and gap analyses of existing validation programs to identify areas for improvement.
• Evaluate equipment design and manufacturing process procedures to establish scientifically sound acceptance criteria for PQ studies.
• Support regulatory submission efforts and inspection preparation and address validation-related observations related to process and cleaning validation.
• Train client personnel on validation principles, methodologies, and best practices.
• Author, Review and approve validation documentation to ensure compliance with cGMP requirements.
• Provide technical expertise and leadership in Stage 2 Process Validation projects for both internal and external manufacturing processes.
• Escalate issues (technical or schedule) as needed both within functional management line and through cross-functional governance structure.
• Manage 3-5 Process Validation and Cleaning Validation direct reports (including contract/consultant support)

Required Qualifications:

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 8 years of experience in biopharmaceutical industry supporting manufacturing in a process validation, cleaning validation, process engineering, MST, process development, or other manufacturing support related capacity.
• Experience with quality risk management tools and methodologies.
• Technical writing and documentation skills.
• Project management and communication abilities.
• Experience with managing a team of direct reports.
• Experience with leading a cross-functional project team.

Preferred Qualifications:

• Experience working with LNP processes and/or process equipment.
• Knowledge of FDA, EMA, and ICH guidelines related to process and cleaning validation or knowledge of how to find/access these regulations.
• Understanding of process design/characterization, equipment design, and CIP/COP systems.
• Familiarity with analytical method development and validation.
• Familiarity with statistical analysis and validation lifecycle approach.
• Familiarity with Smartsheets as a project management tool.
• Must be able to travel up to 25%.