Process Engineer (API) - Dublin.
Process Engineer sought for bulk API manufacturing plant.
• Provision of technical support to the operational areas and engineering personnel in order that operations are conducted efficiently and approved production and project schedules are achieved.
• Responsible for the Distributed Control System and other control systems in operational areas. Ensuring system compliance with all site standards and procedures. This includes maintaining a high level of system operational performance.
• Responsible for ensuring that the administration of GMP computerised systems in your remit is carried out in a manner which ensures the integrity of the data created, modified, or maintained on the systems.
• Conduct incident & deviation investigations within the department in an efficient and timely manner to meet procedural timelines for review and close out, including liaising with others either within or outside the department as required.
• Lead proactive problem solving efforts and resolve process equipment issues, diagnose technical problems and determine short-term and long-term solutions.
• Responsible for expediting CAPA implementation pertaining to raised incidents/deviations in line with target completion dates.
• Manage and/or support projects and other initiatives, which may be of a technical or non-technical nature. Working closely with cross-functional teams as required.
• Manage and/or support activities to maximise value (e.g. increase revenue, reduce costs) such as (but not limited to) process optimisation, waste reduction/recycling, energy saving etc.
• Co-ordinate continuous improvement activities in the area through the application of Lean Six Sigma. Lead CI forums to identify and review the progress of improvement initiatives to ensure benefits are realised. Report on area performance.
• Manage and/or support technology transfer for new technologies and processes, as required.
• Participate in training of staff so that staff are well trained to safely and effectively carry out their roles in the organisation.
• Promote and encourage strong teamwork both internal and external to your department.
• Work with management and staff to foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
• Ensure compliance with relevant regulations and standards associated with cGMP, ISO 14001, EMAS, Health & Safety Legislation and Environmental Legislation, and also all site standards, policies, and procedures. Support other sections to ensure such compliance also.
Interested applicants should have:
• B.S. in Engineering, Chemical / Biochemical discipline or equivalent.
• Minimum 2 to 4 years’ experience, preferably in a similar role.
• Experience in a cGMP API environment is preferred along with technical proficiency, including: broad understanding of centrifugation and purification technologies and processes, experience with process control systems, process instrumentation, equipment qualification, and process validation.
• Possess excellent organisational, interpersonal, verbal communication and written communication skills.
• Able to work effectively using own initiative or as a member of a team as required.
• Be able to prioritise multiple commitments and technical projects.
• Be able to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
• Ability to successfully progress projects independently, provide process engineering design, implementation/commissioning services and maintenance support of cGMP manufacturing.
• Provide significant contributions on project teams and may lead multi-functional teams.
• Proven analytical and problem solving skills including Lean Six Sigma proficiency to at least Yellow Belt level.
• Be committed to continuous improvement.
• Experience of control systems (DCS, PLC) would be an advantage.