Project Validation Engineer, Life Sciences
- Support the execution of site strategy under the direction of the Site Lead, contributing to specific project tasks that align with Project Farma’s services.
- Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols
- Identify and reports client needs or project challenges to the Site Lead for further action.
- Maintain professional relationships with project team members and client POCs at the operational level (e.g., technicians, engineers) to facilitate task completion.
- Contribute to project-level success by delivering high-quality work that supports business growth opportunities.
- Provides data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards or expansion discussions.
- Participate in project tasks that support extensions or proposals, such as preparing deliverables for clients.
- Build meaningful internal and external relationships.
- Present Project Farma as a service to clients as needed.
- Communicate with clients in a professional manner.
- Ensure any client feedback or opportunities identified are being escalated properly.
- Focus on professional development and support team collaboration under the Site Leads guidance.
- Share technical knowledge with peers to support project delivery.
- Provide input on task-level resource needs to the Site Lead to support project delivery.
- Report workload or skill gaps within assigned tasks.
- Assist in maintaining project schedules by communicating resource constraints.
- Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, Engineering and Project Controls
- 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.
- 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.
- 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.
- Support necessary billables as forecasted by site dashboards on billable targets per month.
- Maintain internal site tools such as site dashboards, deliverable trackers, etc.
- Continually develop technical aptitude of Project Farma’s core services within the life science space including but not limited to: Capital Project Management, Facility Builds, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial.
- General understanding of Earned Value Analysis (EVA) and PO management tool
- Analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making.
- 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.
- Maintain 100% individual billability by completing assigned project tasks.
- Escalate any roadblocks on achieving billable targets to the site lead.
- 0-4 years’ experience in consulting and/or engineering services.
- Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience).
- Full-time on-site client presence
- Willingness to travel up to 100% or as required.
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