Engineer V

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