Engineer Jobs in San Diego County, CA

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2d ago

Engineer V

cGMPnow San Diego County, CA 🇺🇸 Remote

San Diego County, CA

2d ago

$145k - $175k/yr Full time AutoCAD BIM Bluebeam Studio

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Job Description

cGMPnow offers a collaborative, impact-driven environment in the San Diego County area with remote options. This Engineer V position carries a salary of USD 145,000 to 175,000 per year and a comprehensive benefits package including 401(k) with matching, health, dental, vision, paid time off, profit sharing, and charitable contributions matching. The role focuses on process, equipment, and project engineering for complex cGMP capital projects in FDA and EU regulated Advanced Therapeutics, with potential pathways into project management and business development.

What you will do

Gather process data and define project requirements
Develop mass balances and assemble detailed equipment lists for complex cGMP manufacturing and laboratory equipment
Create process description narratives, process flow diagrams (PFDs), and P&IDs
Generate User Requirement Specification documents
Collaborate with facilities, manufacturing, technical operations, and facility planners to address process needs including equipment, space, adjacencies, and flows
Work with the PM and discipline leads to ensure process deliverables are on time, coordinated, and within budget
Research process equipment providers and make recommendations based on project requirements
Write process equipment specifications for complex cGMP manufacturing and lab equipment
Define testing requirements and participate in factory acceptance tests (FATs)
Verify receipt of manufacturing, lab, and process utility equipment
Specify and coordinate installation, startup, and commissioning services by vendors or third parties
Write and update SOPs for new process and project implementations
Support post-construction activities, reviewing submittals, RFIs, and field verification of process scope
Support CAD and Designer staff
Stay current with industry technologies and cost implications of various solutions
Assist the project manager with deliverables per the PEP, budget, schedule, and Quality Plan
Support successful project execution using client procedures and industry best practices
Manage project changes in scope, schedule, and budget
Identify and mitigate project risk
Support project team meetings and report progress against deliverables
Support daily activities of technical and administrative staff, including training management, meeting minutes, decision logs, and organizational updates
Help manage client relationships and maintain client satisfaction
Assess cost and schedule impacts from client scope changes
Monitor budgets and schedules and prepare periodic reports
Oversee capital and maintenance projects from inception to turnover to user groups
Coordinate all technical activities on assigned projects and recognize technical issues
Support management of RFPs and approval of submittals
Oversee the work of Engineers
Lead project meetings with user groups and stakeholders
Contribute to draft proposals in response to client RFPs, including PEPs, staffing plans, schedules, cost estimates, and EV tracking tools
Identify opportunities to market services to clients and maintain ongoing client contact
Prepare detailed project cost estimates and schedules
Author proposals for small to medium sized projects (<$1M)
Lead team efforts to develop large proposals ($1M+)
Ensure proposal alignment with the cGMPnow Business Plan and brand
Document proposal status in the proprietary cGMPnow RFP Log system

What you bring

B.S. in Chemical, Biological, Biopharmaceutical, or a related engineering field
6+ years total experience in a GMP-regulated industry
4+ years in process design and engineering project management or PM support within Pharmaceutical, Biopharmaceutical, or Biotechnology sectors
Experience and working knowledge of cGMP compliance
Familiarity with FDA, EMA, and other pharmaceutical regulatory standards
Knowledge of PIC/S, ISPE Baseline & Good Practice Guides, and ASME BPE
Experience with Advanced Therapeutics Medicinal Products (ATMPs) such as autologous and allogeneic cell therapy, gene therapy, viral vectors, stem cells, mRNA, and plasmids
Experience with cGMP products including fermentors, bioreactors, mixers, pumps, chromatography, TFF, spray dryers, isolators, and vial/bag fillers
Experience with Process Gas Systems, WFI, Clean Steam Generators, Autoclaves, CIP Skids, Cleanroom HVAC, and QC laboratory equipment
Ability to apply risk assessment methodologies to projects
Capability to lead a small project or a segment of a larger project from an engineering perspective
Excellent verbal, written, and presentation skills
Strong ability to communicate and collaborate with staff at all levels
Must be eligible to work in the US without sponsorship now or in the future

Technologies and tools

Google Suite (Docs, Sheets, Slides)
BlueBeam Studio
Revit
Microsoft Office Suite (Word, Outlook, PowerPoint, Excel)

Benefits

401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Profit sharing
Charitable contributions matching

Physical requirements

Intermittent physical activity including sitting, standing, walking, bending, stooping, and crouching; occasional lifting up to 25 pounds
Ability to talk, hear, stand, sit, and type or input data using a computer and monitor for up to 8 hours per day
Normal manual dexterity and eye-hand coordination

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