Engineering Project Manage

Sepragen Corporation; Union City (CA); On-site; USD 125,000 - 140,000; Full time

Job summary

Sepragen Corporation in Union City, CA seeks a technically strong Engineering Project Manager to lead multimillion-dollar custom bioprocess equipment projects from customer requirements through final acceptance. You will own scope, schedules, budgets, and customer satisfaction, reporting to the COO.

The role requires coordinating mechanical, process, electrical, software, and manufacturing activities, preparing engineering documentation, and guiding supplier and QA activities to deliver on

Qualifications

• Bachelor’s degree in mechanical engineering or related field.
• 5+ years in engineering and project management for custom process equipment.
• Proven track record leading multiple high-value projects from design to customer acceptance.
• Ability to lead cross-functional teams without direct reporting authority.
• Strong negotiation and commercial judgment; manage scope and change orders.
• Knowledge of mechanical design, fabrication, piping, process instrumentation.
• Ability to prepare and review drawings and procedures using CAD.
• Experience with equipment automation and software integration.
• Clear written and verbal communication; problem-solving and follow-through.
• Proficiency with project scheduling, budgeting, cost-tracking.

Responsibilities

• Own project delivery across multiple concurrent projects; manage scope, schedules, budgets, and milestones.
• Lead cross-functional execution across mechanical, process, electrical, controls, software, manufacturing, quality, procurement and service.
• Manage customer relationships, expectations, and change orders.
• Integrate engineering and manufacturing; coordinate design, fabrication, and system integration.
• Provide hands-on engineering support; review P&IDs and drawings.
• Lead testing and customer acceptance activities per contract.
• Coordinate software functionality and interfaces with data systems.
• Manage supplier commitments and recovery plans.
• Report project performance, risks, and action plans to stakeholders.
• Maintain organized project records and documentation.

Skills

Experience leading complex projects

Negotiation and commercial judgment

Cross-functional leadership without直 |

Education

Bachelor’s degree in mechanical engineering

Tools

CAD

Project scheduling tools

SCADA/PLC interfaces

Job description

Reports to: Chief Operating Officer (COO)

Position Summary

Sepragen seeks a technically strong, hands-on Engineering Project Manager to lead multiple, multimillion-dollar custom bioprocess equipment projects from customer requirements through final acceptance, with responsibility for technical performance, schedules, budgets, and customer satisfaction.

Our systems include sanitary 316L stainless steel, plastic, and single-use chromatography columns; batch and continuous chromatography skids; and buffer preparation systems.

Reporting to the COO, this position requires sound engineering judgment, effective negotiation, decisive leadership, and consistent follow-through. The Engineering Project Manager establishes clear commitments, identifies problems early, resolves competing priorities, and holds project stakeholders accountable. The role also requires the technical depth to evaluate designs, resolve engineering issues, and personally prepare engineering documentation when needed.

Key Responsibilities

• Own project delivery. Establish and manage project scope, schedules, budgets, resource requirements, and milestones across multiple concurrent projects. Track performance, anticipate obstacles, and implement corrective actions to support delivery dates, cost targets, and project margins.
• Lead cross-functional execution. Coordinate mechanical, process, electrical, controls, software, manufacturing, quality, procurement, and service activities within a matrix organization. Establish responsibilities and deadlines in coordination with department leaders, monitor commitments, and escal…
• Manage customer relationships and negotiations. Serve as the primary technical and commercial project contact within delegated authority. Establish realistic expectations, obtain timely decisions and approvals, and negotiate and document change orders addressing scope, price, and schedule.
• Integrate engineering and manufacturing. Coordinate design, fabrication, assembly, and system integration. Resolve technical issues and ensure project decisions support customer specifications, quality requirements, and contractual commitments.
• Provide hands‑on engineering support. Prepare and review specifications, piping and instrumentation diagrams (P&IDs), engineering drawings, component selections, test procedures, and operating documentation. Apply practical knowledge of sanitary design, materials, machining, surface finishes, welding, fluid handling, and instrumentation.
• Lead testing and customer acceptance. Coordinate user requirements specifications (URS), functional design specifications (FDS), design qualification (DQ), factory acceptance testing (FAT), site acceptance testing (SAT), and installation and operational qualification (IOQ), as required by contract. Establish acceptance criteria, ensure test readiness, resolve deviations and punch‑list items, and obtain final acceptance.
• Coordinate automation and applicable technical requirements. Define software functionality and interfaces with customer control and data systems, including chromatography data systems (CDS), where specified. Coordinate implementation, testing, and documentation with technical specialists. Engage appropriate specialists and third‑party organizations for applicable CE marking, ATEX, and ASME requirements.
• Manage supplier commitments. Coordinate with procurement and technical teams to establish supplier specifications, quality expectations, costs, and delivery commitments. Address shortfalls and implement recovery plans.
• Report project performance. Provide customers, the COO, and other stakeholders with accurate status reports, financial forecasts, project risks, required decisions, and action plans.
• Maintain project records. Keep requirements, approvals, changes, technical decisions, test results, and acceptance documentation organized and current.

Required Qualifications

• Bachelor’s degree in mechanical engineering or a closely related engineering discipline.
• Five or more years of relevant engineering and project management experience in custom process equipment manufacturing.
• Demonstrated success managing multiple complex, high‑value equipment projects from design through customer acceptance, including responsibility for schedules and budgets.
• Ability to lead cross‑functional teams without relying on direct reporting authority, establish expectations, resolve disagreements, and secure timely results.
• Strong negotiation skills and commercial judgment, including managing customer expectations, controlling scope, and securing change orders.
• Practical knowledge of mechanical design, equipment fabrication and manufacturing, sanitary piping, valves, and process instrumentation, including flow, pressure, pH, UV, and conductivity sensors.
• Ability to prepare and review engineering drawings, specifications, and procedures using CAD and appropriate engineering tools.
• Working knowledge of equipment automation and software integration sufficient to evaluate requirements, coordinate specialists, and resolve system interface issues.
• Clear written and verbal communication, sound problem‑solving skills, and consistent follow‑through.
• Proficiency with project scheduling, budgeting, and cost‑tracking tools.

Preferred Qualifications

• Experience with bioprocess, pharmaceutical, biotechnology, or life sciences equipment, particularly chromatography and buffer preparation systems.
• Experience with Good Manufacturing Practice (GMP) equipment documentation and qualification.
• Familiarity with applicable CE marking, ATEX, or ASME requirements.
• Experience with PLC/HMI or SCADA systems and integration with customer automation and data systems.
• PMP certification or equivalent project management training.

Working Environment and Essential Functions

This position includes office work and hands‑on engineering involvement in manufacturing and assembly areas. Travel to customer and supplier sites is required as project needs dictate.

Essential functions include reviewing and preparing technical documents, coordinating project activities, participating in equipment inspections and testing, and communicating with customers, suppliers, and internal teams. Employees must follow applicable site safety requirements, use required personal protective equipment, and comply with cleanroom procedures where applicable.

Essential functions may be performed with or without reasonable accommodation.

Compensation

The anticipated annual base salary range for this position is $125,000-$140,000. The starting salary within this range will be determined using job‑related factors, including relevant experience, education, training, demonstrated skills, and internal equity.

Measures of Success

• Projects meet agreed technical requirements, delivery dates, budgets, and customer acceptance criteria.
• Risks and problems are identified early and addressed through effective corrective actions.
• Scope changes are documented, approved, and commercially controlled.
• Project stakeholders have clear responsibilities, timely information, and consistent follow‑through.
• Project documentation is accurate, complete, and delivered as required.

Equal Employment Opportunity and Reasonable Accommodation

Sepragen is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, religious creed, national origin, ancestry, age, sex, pregnancy, childbirth, breastfeeding or related medical conditions, gender, gender identity or expression, sexual orientation, marital status, medical condition, genetic information, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.

Sepragen provides reasonable accommodations to qualified applicants and employees with disabilities and for sincerely held religious beliefs and practices, as required by law. Applicants who need an accommodation during the application or interview process may contact Sepragen Human Resources.