Execute specific technical tasks within a project, ensuring high-quality deliverables.
Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead’s guidance.
Report technical issues to the Site Lead and support resolution efforts.
Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards.
Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
Identify and close individual knowledge gaps with support from other team members or leads as needed.
Execute system and process validation protocols by using GxP best practices.
Support necessary billables as forecasted by site dashboards on billable targets per month.
Report workload or skill gaps within assigned tasks.
Communicate updates internally in a timely manner and relay in-field project decisions to highlight long-range, down-stream project and team impacts.
Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
Perform due diligence on system and subject domains to generate high-quality project deliverables.
Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem- solving skills to identify creative solutions to those problems and roadblocks.
General understanding of Earned Value Analysis (EVA) and project management tools
May be requested to assist with Project Controls and Scheduling to include; Budget estimates, detailed project schedules and milestones, feasibility estimates, risks, forecasts and scenario analysis and project cost reports and analysis.
