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Details
Process Engineer - Technical Specialist
Reference: | AMC22089 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Product Development Engineer
AMC22089
Process Engineer/Technical Specialist
11 month contract
On site - Cork
We are currently looking for a Technical Specialist to join the Vaccine manufacturing team for a biopharmaceutical plant in Cork. In this role you will ensure on-going optimization of the process to ensure the continued manufacture and supply of quality pharmaceutical products.
This is the ideal role for someone with a technical degree and 3-5 years experience in a technical role within Pharmaceutical manufacturing.
Key Responsibilities:
- Own, plan, and execute continuous improvement projects, leveraging Lean manufacturing principles to enhance processes.
- Engage in equipment qualification processes (IQ/OQ to PQ) and draft associated operational Standard Operating Procedures (SOPs).
- Lead and contribute to problem-solving initiatives across various IPT areas (e.g., Reliability, Safety, and Quality—such as CAPA/QNs).
- Manage and close process-related deviations and reports efficiently.
- Serve as the first point of contact for frontline technical Environmental, Health, and Safety (EHS) support and provide coaching for operational teams. Address safety-related issues, including management of change, permits, and risk assessments.
- Author, execute, and oversee protocols and reports, ensuring proper approval where necessary.
- Uphold the highest standards of quality, compliance, and safety across operations.
- Provide ongoing coaching to cross-functional teams, sharing expertise in process engineering and maintenance best practices.
- Guarantee product quality by ensuring optimal equipment availability and enhancing team performance through continuous improvement.
- Contribute technical, process, and engineering expertise across a wide range of IPT projects, including the introduction of new equipment and processes.
- Authorize and approve change controls and MIDAS documents as required.
- Troubleshoot and optimize operations within the Vaccine Processing Unit, including areas such as cleaning, sterilization, upstream and downstream processes, lyophilization, buffer preparation, PSA, and material flow.
- Lead efforts to maintain compliance with MMD Quality Management Systems (QMS), taking ownership where necessary.
- Drive a culture of reliability and continuous improvement through tactical implementation of technical processes and reliability initiatives.
- Foster a culture of continuous improvement, integrating digital solutions to enhance operational reliability.
Qualifications & Experience:
- A Level 8 honours degree in a relevant discipline, such as science, engineering, or manufacturing.
- 3-5 years of experience in a highly regulated manufacturing environment in a technical or support role.
- Strong knowledge and practical experience in applying Lean Six Sigma and Lean methodologies, with a solid understanding of regulatory and validation requirements.
If you are interested in this posting apply today!
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS