Position Details

EDUCATION
    A minimum of a Masters degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). A PhD. is desirable.

EXPERIENCE
    At least 5 years experience in the biotechnology and/or pharmaceutical industry, with Operational experience of new product introductions and product support.  
    Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
    Experience in authoring, review and execution of process validation studies and reports is a must.
    Experience with vaccines would be preferable particularly in the area of product development and stewardship.
    Experience in cleaning validation is desirable. 
    Proficient in written and spoken English.  

RESPONSIBILITIES
    Plan and coordinate the assigned Technical Transfer (TT) activities to ensure a successful transfer of processes and technology. This will include:
•    Developing instructions relating to production operations (tableting/packaging)
•    Review and report on data relating to TT activities
•    Working with the scheduling team to schedule TT activities
•    Support the Manufacturing team throughout the manufacturing process 
•    Developing protocols as required
    Focus on assigned Technical Transfer (TT) activities for new products and filling and inspection processes being transferred into the Sligo site.
    Use a risk-based approach to TT activities for planning, readiness & execution. 
    Develop functional partnerships with the required site business units to address TT activity related issues.
    Continuously support the manufacturing processes through:
•    Provide on the floor process support with enhanced support during Engineering runs
•    Introduce/Establish statistically based tracking metrics
•    Continuously monitor process CPP’s and update the process databases
•    Raise, investigate and close out non conformances, planned deviations and change control requests
•    Where required performs sample analysis in accordance with standard operating procedures (SOPs)
•    Coordinates the use of external test laboratories when required
•    Present issues relating to TT and routine process monitoring activities to cross functional teams and help develop and deliver business cases for courses of action as appropriate

    Develop and maintain the depth of knowledge and commitment to excellence necessary for the manufacture of biological products.
    Conduct work activities in compliance with Safety, Health and Welfare at Work legislation and Company policies.
    Engage with and Support Quality and Regulatory Audits 
    Other duties as assigned

CORE COMPETENCIES
    Proactive at keeping current with literature and latest technologies.
    An excellent understanding of GMP, ICH and compendia regulations and guidance's.
    Demonstrated ability in leading root cause analysis and effective investigation practices.
    Excellent problem solving (facilitation and application of tools), risk management and decision making skills
    Excellent collaboration skills.
    Excellent attention to detail and significant data review experience essential.
    Excellent technical writing skills including deviation reports and validation reports.
    Effective time management and multi-tasking skills.
    Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail.
    Excellent communication skills, both verbal & written.