Validation - Lead Engineer - Project Farma

Responsibilities

• 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.
• 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.
• Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, Engineering and Project Controls
• 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, 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.
• Analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making

Talent Development

• Focus on professional development and support team collaboration under the Site Leads guidance.
• Share technical knowledge with peers to support project delivery. Mentor less experienced team members.
• Participate in Project Farma internal qualification training program.

Site Strategy

• 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

Resource Management

• Provide input on task-level resource needs to the Site Lead to support project delivery.
• Report workload or skill gaps within assigned tasks.
• Aid in maintaining project schedules by communicating resource constraints.

Business Growth & Development

• Contribute to project-level success by delivering high-quality work that supports business growth opportunities.
• 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.
• 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.
• Identify opportunities for cross-selling and up-selling of additional Project Farma services outside of the Validation dicscipline.

Operational Performance & Billability

• Maintain 100% individual billability by completing assigned project tasks.
• Escalate any roadblocks on achieving billable targets to the site lead.