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Unispace Life Science are delighted to be recruiting for a global pharmaceutical company based in Cork,
This is an initial 12-month contract (hourly rate) available for a Process Engineer, we require an experienced professional from the pharmaceutical or life sciences sector.
The Process Engineer (Aseptic filling process) is responsible for supporting the site manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE). He / she will also be responsible for the management of small / medium process improvement projects within the sites aseptic filling manufacturing areas, The candidate will have knowledge and proficiency in the use of statistical analysis tools, project management methodologies, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and associated Process automated system.
DUTIES AND RESPONSIBILITIES:
- Perform troubleshooting of issues identified during operations.
- Lead manufacturing investigations, CAPA’s and Change Controls and ownership of Deviations within the sites Quality System (Trackwise).
- Collation and Analysis of manufacture performance data to help focus improvement efforts. Eg. Pareto, FMEA, DOE, 8D, 5-Why, Root Cause Analysis
- Provide technical leadership by acting as ‘System Owner’ to drive improvements and excellence within specific aspects of the manufacturing operation.
- Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
- Aid and/or support maintenance, engineering, quality, or other colleagues as required.
- Assist / Lead Facility and Equipment Validation activities.
- Execution of Continuous improvement projects within the sites aseptic filling manufacturing areas
- Work closely with the technical operations manager to define, prioritise, and develop projects plans, including setting deadlines, prioritizing tasks, and deliverables.
- Manage project approval progress tracking, monthly reporting, and forecasting.
- Interface externally with external engineering consultants, major equipment vendors and Corporate Engineering
- Play a key role in the review, approval and execution process of Engineering and Validation lifecycle documentation
- Coach wider team on process knowledge, chemistry and build mastery among team.
- Remain current on state-of-the-art for systems, and for the appropriate adoption and use of new techniques and technology.
- Represent the client with outside firms, technical societies, standards organizations and regulatory bodies.
- Oversee the development, revision, review, and approval of Standard Operating Procedures that are owned by Technical Operations department.
- Ensure adherence to standards and good engineering practices.
- Use their network to provide engineering support to the commissioning team, to resolve escalated technical issues and conflicts, as required.
QUALIFICATIONS
- Degree in Chemical Engineering, Process Engineering or associated Discipline.
- Significant engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging and Devices.
- Ability to read/interpret engineering drawings and design documents.
- Excellent technical writing and verbal communication skills
- Good technical knowledge of project engineering principles i.e. all phases of project life cycle - URS through to hand-over
- Fluent in the needs of validation FAT to PQ (protocol generation, review, execution and reporting)
- Knowledge of cGMP/GAMP requirements
- Experience with Six Sigma and Lean Manufacturing methods would be an advantage.
- Proficiency in the use of quality management systems, with experience in the use of Track wise software being an advantage.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio
- Strong problem solving and decision-making skills and attention to detail.
- Strong interpersonal skills and the ability to communicate across functions.
- Ability to manage time independently, tasked with short term reactionary duties as well as long term strategic projects.
