Description
Process Engineer – Dublin
Reporting to the Lead Pharma Manu Technical Operations DP your role as a Process Engineer.
Key responsibilities will include (but will not be limited to).
- 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 Lead Pharma Manu Technical Operations DP in the provision of operational expertise in all areas relating to the role.
- To take direction from the Lead Pharma Manu Technical Operations DP 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.
- 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, ISO 45001, 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 Lead Pharma Manu Technical Operations DP.
Skills and Experience required for the role.
- 2 to 4 years’ experience, preferably in a similar role.
- 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.
- Proven analytical and problem-solving skills including Lean Six Sigma proficiency to at least Yellow Belt level.
- Is committed to continuous improvement.
- Experience of control systems (DCS, PLC) would be an advantage.
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword – it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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