Summary:
Our client, a biopharmaceutical company located in Louth, is seeking a
Technical Support Specialist
to provide technical leadership within Drug Product manufacturing. The ideal candidate will support formulation, filling, lyophilisation, capping and automated visual inspection operations, and will work closely with cross functional teams to support commercial manufacturing, new product introductions, equipment qualification and continuous improvement activity.
Responsibilities:
* Provide technical leadership and SME support across DP operations including formulation, filling, lyophilisation, capping and automated visual inspection
* Coordinate technical deliverables to support successful product launch activity
* Provide technical oversight and support to commercial manufacturing operations
* Lead or participate in manufacturing investigations to ensure robust root cause analysis and implementation of CAPAs
* Support Batch Disposition activities through provision of technical commentary resolution
* Identify and implement continuous improvement projects to enhance compliance and manufacturing capability
* Support Lean Six Sigma deployment within DP operations
* Create and revise technical documentation including MBRs, SOPs and technical memos
* Act as technical point of contact during audits and inspections
* Support execution of equipment qualification activities including FAT, SAT, IQ and OQ
* Act as delegate for the Manufacturing Technical Lead as required
Qualifications & Experience:
* Bachelor's degree in Engineering or Science related discipline required
* 3 plus years' experience in biopharmaceutical, pharmaceutical or vaccine manufacturing
* Previous sterile manufacturing experience preferred
* Experience in equipment qualification activities (FAT, SAT, IQ, OQ)
* Strong experience in leading complex technical investigations
* Experience applying risk-based tools such as FMEA
* Lean Six Sigma experience