Manager – Cleaning Validation • Validation Engineering

Manager – Cleaning Validation • Validation Engineering

Requirements

• Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
• A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.
• Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.
• Experience in establishing site and program validation strategies that are aligned with current industry mindsets.
• Understanding of the US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.
• Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
• Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.

Responsibilities

• Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.
• Establish and implement the cleaning validation philosophies and master plans required to drive the cleaning validation lifecycle.
• Responsibilities include oversight of cleaning validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs.
• Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.
• Manage multiple projects.
• Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality.
• Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.
• Leads and/or executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies.
• Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on cleaning validation matters.
• Supports internal compliance and/or efficiency improvement efforts within department for more complex processes.

Preferred Qualifications

• Understanding of lean principles and establishment of effective process metrics is preferred.
• Project management, communication, and technical writing skills are required.
• Ability to develop and apply new and innovative approaches to projects and processes.
• Must be able to influence others.
• Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.
• The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.