Downstream Manufacturing Engineer
Reference: | AMC21598 |
Location: |
Dublin North
|
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
AMC 21598
Downstream Manufacturing Engineer (Drug substance)
11 month contract
On site - Swords (Hybrid role)
We are looking for a Downstream manufacturing Engineer to work with the Days Operations Team at a world leading biopharmaceutical manufacturer based in North Dublin.
To be successful in this role you MUST have three years' experience in a pharmaceutical environment (preferably drug substance) including GMP change management and Quality Investigation Writing experience.
Responsibilities
- Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.
- Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.
- Own Quality Investigation from identification through root cause analysis
- Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs.
- Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
- Act as a link between the shift operations team and days team, ensuring standardization and integration between all IPT teams.
- Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
- Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures.
- Drive MPS standards within the area and ensure team alignment on same.
- Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.
- Provide ongoing coaching and support to cross functional team members, to share process and operational best practices.
- Act as days operations member on process centered teams(PCT), working with technical operations and shift operations to identify, perform root cause analysis and develop corrective/ preventative actions for issues as they are occur.
Requirements
- A Level 7 Degree in Science, Engineering or other relevant disciplines/ relevant experience.
- At least 3 years’ experience in the Pharmaceutical industry (preferably in Drug Substance)
- Experience in change management in a GMP environment.
- Experience in technical writing for GMP documentation and quality investigations.
- Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
- Experience working with GMP Documentation Management Systems
If you are interested in this posting please apply today or feel free to contact Angela McCauley on +353 (0)87 693 0951 or angela.mccauley@lifescience.ie for further information.