12 month contract Role Responsible for Generation, Execution / Approval of Qualification Life Cycle documents from SLIA through to PQ and Final Summary Reporting for Direct Impact Systems.
Generation of Commissioning Test documents for No Impact Systems.
Implementation of Change Controls on the change management system to support project activities as applicable.
The role requires someone to coordinate and manage all elements of commissioning & qualification of large- and small-scale projects.
Responsibilities: Developing a project plan and qualification strategy in line with requirements.
Process equipment, Clean Utilities, HVAC & Facilities.
Coordinate and supervise third party suppliers / vendors , service providers and sub-contractors as necessary.
Monitor and report on project plan progress, communicate any shortfalls in specific areas of the plan and where needed identify solutions to address the shortfalls.
Organise and or attend any necessary meetings that are required for progress gathering or plan alignment Participate in decision forums to decide on priorities and ensure these are reflected in the plan, schedule and communications.
Evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.
To communicate with project stakeholders required support and completion dates.
If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress Qualifications: BS Degree in engineering or technical discipline.
3 - 5 years of experience.
Essential: An understanding of basic unit operations involving cell culture and protein purification Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is desired Familiarity with Clean-In-Place and Steam-In-Place theory and techniques Experience with risk-based approach to commissioning and qualification Experience with temperature mapping of environmental chambers, autoclave validation Familiarity with distributed control systems and process logic controllers Familiarity with P&IDs, loop diagrams, etc.
Hands-on experience with the Kaye Validator Familiarity with project management Experience with continuous improvement to streamline practices & procedures Adherence to cGMP and GDP Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment Able to work independently with adequate supervision, multi-task and support several projects simultaneously Must demonstrate strong interpersonal & teamwork skills Significant Skills: Autoclave WFI Distallation Medical Devices