Process Engineer
- Ireland, Midlands (Ireland)
- Contract
- Life Sciences
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer, Tech Transfer/NPI, to join their team to support multiple capital projects taking place onsite in Carlow.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
- 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.
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
- Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
Skills and Knowledge:
- 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
- Report, standards, policy writing skills required.
- 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
If you are interested, please apply now for immediate consideration and further information.
#LI-TE1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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