Project Engineer / Senior Project Engineer
Location: San Diego, California, US, Remote
Employment Type: Regular
This is a fully onsite role in the San Diego, CA area with Project Farma, a Perkin Elmer Company.
Project Engineers (PE) and Senior Project Engineers (Senior PE) are fully billable roles that will work collaboratively with clients, vendors, contractors, and other Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. PEs and Senior PEs are responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening their technical and industry knowledge. They will maintain a strong focus on Project Farma’s Patient Focused and People First mindset.
Key Responsibilities
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.
Business Growth & Development
- 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.
Talent Development
- Focus on professional development and support team collaboration under the Site Leads guidance.
- Share technical knowledge with peers to support project delivery.
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.
- Assist in maintaining project schedules by communicating resource constraints.
Technical Delivery
- 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.
Operational Performance & Billability
- Maintain 100% individual billability by completing assigned project tasks.
- Escalate any roadblocks on achieving billable targets to the site lead.
Experience Required
- 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).
Other Required
- Full-time on-site client presence
- Willingness to travel up to 100% or as required.
Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.
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