Pharmaceutical Operations Specialist

7 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time
Downstream Manufacturing Position with a Leading Biopharmaceutical Company

We are seeking a skilled professional to join our team as a Downstream Manufacturing Engineer in our biopharmaceutical organization based in Swords. As a key member of the Integrated Process Team (IPT), you will play a critical role in ensuring the timely delivery of production schedules while maintaining alignment with site safety and quality standards.

Main Responsibilities
  1. Material Management Oversight: Provide leadership on material management, ensuring that quality and delivery metrics are consistently met.
  2. Quality Investigations: Own quality investigation processes from identification to root cause analysis, driving corrective and preventive actions.
  3. Production Quality Metrics: Oversee daily production quality metrics, ensuring timely documentation closure, line clearance, and material management adherence.
  4. Continuous Improvement Projects: Drive initiatives focused on improving schedule, equipment, and delivery capabilities within the DS IPT.
  5. Integration and Standardization: Facilitate seamless collaboration between shift operations and day teams, promoting standardization and integration across IPT teams.
  6. Root Cause Analysis: Conduct RCA sessions for safety and quality-related incidents, developing and implementing corrective actions.
  7. MPS Standards: Promote and enforce MPS standards within the area, ensuring team alignment.
  8. Change Controls and Documentation: Lead/support area change controls, CAPAs, QSAT actions, and document updates as required.
  9. Cross-Functional Support: Provide ongoing coaching and support to cross-functional team members, sharing process and operational best practices.
  10. Process Centered Teams: Act as a day operations member on PCTs, collaborating with technical operations and shift operations to resolve issues and develop corrective actions.
Requirements
  • Bachelor's Degree in Science, Engineering, or relevant field, or equivalent experience.
  • At least three years of experience in the pharmaceutical industry, preferably in drug substance manufacturing.
  • Desirable experience in multiple site functions, including quality, engineering, or supply chain.
  • Proven track record in change management within a GMP environment.
  • Technical writing skills for GMP documentation and quality investigations.


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