Process Engineer

Job Description

This is an exciting opportunity for someone with an engineering/chemical/biochemical background to work as a Process Engineer in a leading Pharmaceutical company in the Dublin area.

Purpose:

• To provide technical support to Manufacturing Operations, including effective investigation/ root cause analysis and implementation of corrective actions, to ensure efficient production operation and to support manufacturing schedule adherence.
• To ensure compliance of the above function with all internal and external regulatory, legislative and statutory requirements. Includes maintenance of production control systems.
• To provide strategic value add operational input and direction in support of the plant's technical operational activities and requirements, including support to projects/ initiatives in the manufacturing areas.
• To support the Manager, Technical Operations in the provision of operational expertise in all areas relating to the role.
• To take direction from the Manager, Technical Operations in the execution of duties assigned as part of the role.
• Actively support the sites Operational Excellence Programme and ensure it is embedded in all aspects of production operations.

Core Tasks:

• 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 DCS 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 resolves process equipment issues, diagnoses technical problems and determines short-term and long-term solutions.
• Responsible for expediting CAPA implementation pertaining to Manufacturing Operations Dept. 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.
• Participate in the preparation, periodic review and update of Production SOPs or related documentation as required.
• Complete assigned LMS training items in line with target completion dates.
• Promote and encourages strong teamwork both internal and external to your department.
• Works 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.
• In support of operations, performs the normal work as carried out by process operators or team leaders as required.
• Other issues as directed by the Technical Operations Manager.

Experience:

• Minimum requirement: B.S. in Engineering, Chemical / Biochemical discipline or equivalent.
• 1 to 2 years' experience, preferably in a similar role.
• Exposure to Automation/ Control Systems an advantage.
• Experience in a cGMP API environment is preferred along with technical proficiency, including: broad understanding of filtration and purification technologies and processes, experience with process control systems, process instrumentation, equipment qualification, and process validation.
• Possesses excellent organisational, interpersonal, verbal communication and written communication skills.
• Ability to work effectively using own initiative or as a member of a team as required.
• Ability to prioritize multiple commitments and technical projects.
• Ability 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.
• Is committed to continuous improvement.
• Experience of control systems (DCS, PLC) would be an advantage.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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