A leading Pharmaceutical Company are hiring a Mechanical Engineer for a new state of the art large-scale biologics manufacturing facility in North Dublin.
As Mechanical Engineer
- Provide engineering support for the Upstream and Downstream Process Equipment and Manufacturing Systems.
- Be responsible for the Manufacturing Equipment within the Bulk Drug Substance building
- Engineering expert for Manufacturing Upstream and Downstream Areas
- Knowledge of process operations and equipment to support Manufacturing, Quality, Automation, Validation, and EHS for deviation investigation, change controls, and CAPA’s.
- Technical expert for equipment and accountable for changes to ensure continued compliance of the manufacturing equipment.
- Ensuring all the systems follow all Regulatory requirements including Quality, EHS, Global Engineering, design & construction standards, requirements & procedures
- Responsible for Clean in Place (CIP) and Steam in Place (SIP) changes and support of Validation
- Accountable for redlining, reviewing and approval of Automation Functional Specifications
- ensuring implementation of software changes to the PAS.
- Review and approval of Drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.
- Supporting internal and external audits as the Engineering SME.
Perfect Person for the Job
- Degree Engineering (Chemical or Mechanical)
- 5+ years’ experience with Biotechnology manufacturing, as well as GMP experience.
- Expertise in upstream and downstream processing and support equipment
- Troubleshooting experience
- In-depth knowledge of DeltaV or other process automation software
- Experience dealing with Regulatory Agencies.
If interested in this job Apply with your CV to Evan Long - Apply TODAY!!
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