
Process Engineer
2 weeks ago
Direct message the job poster from RT.Lane
Director at R.T.Lane Recruitment 022 46969 or 087 9669394rachel@rtlanerecruitment.ieProcess Engineer II - Experience of Technical Transfer, NPI within GMP environment is essential for this role.
Please reach out today for an immediate response - Rachel 087 9669394 rachel@rtlanerecruitment.ie
Role:
- Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
- Design/Author/Review/Approve/Execute Execution/development of change controls
- Contribution to Kaizen events as appropriate
- Technical input into quality notification by authoring/reviewing/approving investigations
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Support continuous improvement through Lean Six Sigma methodologies
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
What skills you will need:
In order to excel in this role, you will more than likely have:
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Min 3 years experience ideally in manufacturing, preferably GMP Setting
- Demonstrable experience of leading technical related projects
- Evidence of continuous professional development is desirable
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications required
- Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Hybrid role once successful completion of training, occasional shift support as required based on program needs
- Seniority levelAssociate
- Employment typeContract
- Job functionEngineering and Manufacturing
- IndustriesManufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
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