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Downstream Manufacturing Support Engineer
1 month ago
- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 1-3 years
- City: Dublin
- State/Province: Dublin
- Country: Ireland
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Role Functions:
- 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 day 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.
- Lead/support area change controls, CAPAs, QSAT Actions as relevant per workstream 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 a 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 occur.
- A Level 7 Degree in Science, Engineering, or other relevant disciplines/relevant experience preferable.
- Experience across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
- Experience in change management in a GMP environment.
- Experience in technical writing for GMP documentation and quality investigations.
- Self-motivated with excellent organizational skills.
- Excellent verbal and written communication skills.
- Proficient in Microsoft Office Tools (Word/Excel/PowerPoint).
- Ability to work independently and as part of a team in a cross-functional collaborative environment.
- High level of attention to detail.
- Experience working with GMP Documentation Management Systems.
- Good interpersonal skills.
Qualifications:
At minimum level 7 in a relevant qualification.
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