Operations and Technical Support Specialist
Pfizer Grange Castle, Dublin
No shift work involved
The purpose of the role is to provide process support to the ongoing requirements of the Bioprocessing OpU. The role primarily focuses on leading/supporting process investigations at the request of the OpU. The role also focuses on routine process technical support and troubleshooting.
Provide SME input into cross-functional teams investigating manufacturing process, deviations including authoring investigation reports, technical assessments and summaries including but not limited to:
• Routine process technical support and troubleshooting
• Write process impact assessments to support investigation closure
• Identify and manage process training requirements
• Support gathering of data for Annual Product Quality Reporting requirements
• Implement process CAPA’s and performance improvements
• Conduct Investigation Trending
The successful applicant will be responsible for ensuring investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
Additional responsibilities include:
• Change Control write up and close out
• Support audit preparation
• Work to implement a culture of Right-First Time through partnerships with Operations and provide leadership in the use of OE principles to optimise our technical and business processes
• SME on process documentation. Responsible for non-project documentation updates and general operations support for the process.
• Assist in completion of biennial review and PQS updates.
• Attend daily investigation meeting.
• Support key meetings in the OpU as required.
• Support OpU initiatives / programs as required
• Generate Suite PBL metrics,
• Represent the suite at site QAR and CAPA effectiveness meeting
• Min qualification – Degree level or equivalent
• 2+ years' Biopharmaceutical experience.
• Minimum of 1 years’ experience in investigations and change controls required.
• Experience in Isolators, Chromatography, and Ultrafiltration would give a distinct advantage.
• Excellent communication skills including computer literacy and ability to work independently and within a Dynamic
• Excellent writing skills and an ability to clearly communicate through written format.