Job Title:
Manufacturing Operations Specialist
Key Responsibilities:
Our ideal candidate will have a strong background in engineering, with excellent leadership and communication skills. He/She will provide technical leadership within a new vaccine drug product manufacturing facility, ensuring that all equipment installed is safe, effective, and compliant with industry standards.
Key Accountabilities:
* Ensure compliance with company and site engineering policies and procedures.
* Provide technical review and authorship of testing protocols, reports, and applicable manufacturing SOPs.
* Generate and execute documentation for cGMP activities, including risk assessments/reports.
* Manage equipment vendors, including on-site maintenance visits, continuous improvement projects, and spare parts criticality assessments.
* Support the validation state of equipment through revalidation protocols as per Site VMP.
* Lead cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
* Manage changes to equipment/process as per site change control procedures.
* Support the establishment of a preventative maintenance program for equipment in the drug product suite.
* Lead/participate in equipment-related manufacturing investigations with cross-functional teams to ensure detailed root cause analysis and impact analysis are completed and appropriate CAPAs are implemented.
* Identify process and equipment improvements and develop these into CI projects.
* Support disposition of batches by addressing any potential technical/engineering-related issues which may have occurred mid-batch.
* Lead/participate in TPM, CI, and Gemba programs and daily/weekly tiered manufacturing meetings.
* Provide technical expertise during regulatory inspections (e.g., FDA, HPRA) to defend systems, change controls, investigations, and qualification packages.
* Support transition from project to sustaining manufacturing and ramp up of production volumes in the future by improving equipment reliability through CI and TPM processes.