Cpl in partnership with our client Pfizer are looking to hire a Manufacturing and Technical Support Specialist
Job Title: Manufacturing and Technical Support Specialist
Position Reports to: Manufacturing and Technical Support Lead
The purpose of the role is to provide process support to the ongoing requirements of the Bioprocessing OpU, with a primary emphasis on leading/ supporting investigations and providing process technical support and trouble shooting. Additionally, the role includes responsibilities for leading /supporting change controls and continuous improvement initiatives, or other supporting activities at the request of the OpU.
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 CAPAs 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
• Represent the suite at site QAR and CAPA effectiveness meeting
Education & Experience:
• Min qualification – Degree level or equivalent
• 3+ 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.
People / Values
• Demonstrate the GC values
• Adhere to all HR Policies as appropriate
• Personal Development plans focus on the 70:20:10 guidelines
• CI tools/- capability is a key building block for learning & development - Trained and M1
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and across shifts