about 1 year ago
I am currently working with a leading global biopharmaceutical organization. They focus on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. They are looking for an experience validation lead to join them in Dublin.
- The Validation Lead will be responsible for developing the validation strategy and maintain validation standards; taking in to consideration the business strategy and the requirements of the organization and critical stakeholders. Furthermore, the role also requires you to provide technical support to meet the objectives of quality, output and cost in developing, trouble shooting, standardizing and improving equipment. You will be also be required to prepare, execute, review, approve and report on validation protocols in line with GMPs and other regulatory requirements and standards.
Summary of Responsibilities
- Maintain, implement and continuously develop a validation strategy and maintain validation standards, ensuring alignment between business strategy and the requirements of critical stakeholders such as corporate, regulatory and legislative requirements
- Lead in the development of Validation goals and objectives to ensure the area achieves the company goals.
- Responsible for providing expert technical support in validation to meet the objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
- To prepare, execute, review, approve and report on validation protocols in line with GMPs and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology and regulatory requirements.
- Oversee the development, revision, review, and approval of all Standard operating procedures that are owned by Validation.
- Develop, maintain and justify the department budgets.
- Strong people and project management skills with proven ability to define and execute the validation elements of a project or NPI into an existing facility from design to routine facility operation.
- Capable of creating a team environment among existing site groups and creating a unified culture within a matrix validation organization across Technical Operations, Engineering and QC.
- Responsible for recruiting talented staff, contractors or managed service providers into the facility and setting standards for their performance in relation to execution of validation activities. Staff performing validation activities will comprise direct reports, matrix reports from other functions and managed services.
- Ensure the appropriate level of training is undertaken for all levels of the validation organisation which may involve developing training material.
- Provide validation support in introducing equipment, process improvements and new products.
- Manage the qualification/validation of production equipment, utilities and systems.
- Ensure that equipment and utilities are qualified to the highest standards and meet the requirements of the regulatory agencies.
- Support, evaluate and assess equipment and process changes.
- Manage the Process Qualification and Cleaning Validation Programs in conjunction with Technical Services ensuring consistency with network validation strategies and standards.
- In conjunction with System Leads/Process Engineers in the Engineering function, ensure that compliant and fit for purpose Requalification and Periodic Review programs are in place and adhered to for equipment and systems.
- Be a champion for safe working practices and safety initiatives within each functional area where validation is performed.
Typically, 10+ years of experience with typically 4+ years’ experience supervising validation/technical staff.
• Current validation subject matter expertise and experience in biopharmaceutical facilities. Experience with complex projects and working in or around operating facilities.
• Ability to keep work pace and meet deadlines. Good organization and planning skills.
• Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
• Ability to build teams and direct the activity of others in matrix, internal or external reporting relationships.
• Proven success working well in a team environment with flexibility to react to changing business needs.
• Development and presentation of execution plans and strategies to senior management.
- Ability to anticipate, evaluate and resolve multiple, simultaneous issues, delays and problems by utilising technical, project management, and business expertise.
• Ability to work independently and remotely with minimum direct supervision.
• Strong Customer relationship management skills.
• Strong Critical thinking skills.
• High level of competence using Microsoft Office Suite particularly SharePoint and MS Project.
• Ensuring compliance with practices, policies, procedures, legal requirements and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources.
- Knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.