Reporting to the Manufacturing Engineer you will be responsible for the management of Production Processes on site. This role is to manage and support the established Products, including Process improvements. You will also actively lead new product introduction: from other manufacturing facilities and scale up from Lab.
Responsibilities
Responsible for the day to day running of API processes, trouble shooting and meeting production schedules.
Ensures yield and quality targets are met.
Leads and supports the production teams to achieve the manufacturing goals.
Forecasts operational requirements/ resources based on future production schedules, projects etc so as to ensure the production targets are met.
Initiates and leads cross functional team investigations for yield and quality issues. Ensures comprehensive follow up and corrective/ preventive actions are in place for Quality and Safety deviations.
Is the Lead person for New Product introduction. This involves designing, implementing and supporting new processes in conjunction with Quality, Safety, Engineering and Technical Services.
Provides technical support and direction to production supervisors and operators.
Is responsible for producing production documentation for new and existing processes, such as Batch Production Records, cleaning documents, URS, etc.
Initiating and leading technical transfer activities for the introduction of new products utilizing best available technology, practices and tools as appropriate. These include the use of Six Sigma, FMEA, Lean Manufacturing, Risk Assessment, Quality by Design, etc.
FULL JOB SPEC ON REQUEST
Requirements:
BSc / Beng, Msc / Meng, PhD in Chemical Engineering or equivalent
3-7 years of industry API experience working within the pharmaceutical industry
Experience in technical manufacturing support
Experience in equipment and technology design, selection and testing
Tech transfer, capital project support, and start-up experience of multiple processes from early stage development to commercial scale.
Experience in Production operations, trouble shooting and creative problem solving within a technical environment
Current knowledge of GMP regulatory requirements in US and EU
Excellent written and verbal communication skills
Excellent problem solving skills
Ability to interact with and be part of multi disciplinary teams
Experience in Delta V systems a distinct advantage
For further information please call Ciara at 01 2784671 or email your CV in the strictest confidence to cbyrne@thornshaw.com .
