Amgen Sr. Manager Validation in Dun-Laoghaire-Rathdown, Ireland
Lead in the development of Validation's vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.
Maintain, implement and continuously develop a Quality Operations strategy with the site leadership team while ensuring alignment between business strategy and the requirements of critical stakeholders such as, corporate, regulatory & legislative requirements.
Responsible for providing expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
To prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Responsible for purchasing function within Validation / Technical Services using the DataStream computer-based purchasing system and the Purchasing Card
Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department.
Develop, maintain, and justify the departments' budgets.
Strong people and project management skills with proven ability to define and execute the validation elements of a project from design to routine facility operation
Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization
Responsible for recruiting talented staff into the facility and setting standards for their performance.
Assure the appropriate level of training is undertaken for all levels of the validation organization which may involve developing training material.
Manage the Technical Services projects-provide technical support in introducing equipment, process improvements and new products.
Manage the qualification/validation of production equipment, utilities and systems directly associated with production equipment/processes.
To ensure that products, manufacturing equipment and utilities are qualified to the highest camp standards and that personnel and equipment records meet the requirements of the relevant regulatory agencies.
To maintain and foster the broader objectives of the company in the Validation department by promoting the spirit of Leadership Behaviours, Company Values and emphasizing the need for teamwork with all departments.
Support, evaluate and assess equipment and process changes.
Provide cost improvement programs, identify and adapt new technology.
Introduce raw material changes when necessary.
Investigate non-conforming product and process and issue recommendations.
Provide support to Quality Assurance in the preparation of Process Change Requests and regulatory submissions.
Design and write batch documentation for all new products for production in line with cGMPs and other regulatory requirement standards
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Be part of a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
Be a champion for safe working practices and safety initiatives within their functional area.
Typically 8+ years of experience in management position. With typically 4+ years experience supervising validation / technical staff
Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering
Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation.
Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan.
Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage.