Process Engineer Lead - Sterilisation
PROCHEM Engineering
Kilkenny, Ireland
Role Summary:
- A fantastic vacancy has arisen for a Sterilisation Process Engineer Lead to join our client’s new manufacturing facility in Co. Kilkenny.
- In this role you will be the Specialist in the Pharmaceutical/Biological Process Sterilisation Sub-Function, considered as highly experienced and knowledgeable resource within the organization in implementing and maintaining pharmaceutical processes.
- You will also have the opportunity to travel to vendor locations for training in Europe and worldwide.
Core Duties and Responsibilities:
As a Process Engineer Lead in e-beam Sterilisation you will be required to:
- Provide product and manufacturing support in a cGMP regulatory environment.
- As part of a cross functional team liaise with equipment suppliers and perform and manage equipment installations. (SAT/FAT)
- Monitor machine performance (OEE/KPI’s) in real time to maximise production output.
- Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions through presentations and reports.
- Coordinate and contribute to the design of Ops, protocols, specifications, and validation documentation (IQ/OQ/PQ).
- Develop and drive the site sterilisation program, updating as appropriate.
- Supervise in implementing and maintaining the sterilisation processes for the site.
- Manage and co-ordinate all sterilisation activities, including coordination with providers and suppliers.
- Model processes and unit’s operations.
- Write documentation for sterilisation process flow, support equipment validation and provide guidance and feedback.
- Ensure equipment maintains its validated state.
- Ensure that all work conducted is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Drive the sterilisation training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
- Seek opportunities for significant, process or product improvements, considering critical quality attributes, critical process parameters, and product performance characteristics.
- Develop and maintain project timelines and provide updates and feedback to leadership.
- Data management, trending (including SPC) and reporting of product performance and other business measures.
- With appropriate training become a subject matter expert in process & product.
- Service, troubleshoot and solves engineering problems with processes or equipment already in operation.
- Ensures processes and procedures are in compliance with regulations.
- Initiate and complete CAPAs and Change Controls in accordance with site procedures.
- Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
- Excellent communication / interpersonal skills
- Proven Technical writing skills with proven capability in providing rationale for equipment and processes.
- Mentor coach and co-ordinate a team.
Minimum Qualifications and Experience:
- A relevant third level qualification in Engineering/Manufacturing/Science, Mechanical, Electrical, Electromechanical is preferred.
- Minimum 5 years’ experience in the Engineering/Manufacturing/ Scientific field.
- Ability to interpret data, discuss findings and resolve complex analytical problems.
- Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues.
- Strong problem solving.
- Strong mechanical and electrical ability with computer experience, MS Excel & Word are essential.
- Computer statistical skills will provide immediate expertise for the trending and reporting of data.
- Must possess good organizational skills and attention to detail.
- Demonstrate Leadership qualities are a distinct advantage.
- Demonstrated flexible and innovative approach to work.
- Electron beam, Gamma, or other sterilisation technologies experience desirable.
- Knowledge in ISO 11137 desirable.
- Travel 15% of time
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