Job Description:
A key contributor is required for an Engineering Specialist (Validation) opportunity. The successful candidate will support Isolator Airflow Visualisation/ VHP/HVAC Qualification activities in a cGMP regulatory environment.
In this role, you will be responsible for Designing and Authoring qualification/validation documentation and cycle development studies in line with the standard approval process. You will also execute Execution/development of change controls, Resolving technical issues encountered during study execution, and Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
You will provide Technical input into quality notification by authoring/reviewing/approving investigations, Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Additionally, you will Support continuous improvement through Lean Six Sigma methodologies, Serve as validation representative for cross functional projects and represent the validation team at global technical forums
Required Skills and Qualifications:
* Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents
* Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
Benefits:
* 11 month contract - Hybrid work model
* Salary depending on experience
* Continuous professional development opportunities
Others:
This role requires a strong analytical skillset, with the ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate. Report, standards, policy writing skills are also required. Experience with Sterile Fill-Finish processes and equipment, Equipment and process validation, Autoclave/SIP Sterilisation Validation, Dry Heat Sterilisation Cleaning Validation Controlled Temperature Units/Equipment Qualification, Vial and Syringe Processing Technologies would be beneficial.