Senior Project Engineer

Tundra Technical Solutions; Fremont (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Tundra Technical Solutions is looking for a Senior Engineer, Equipment to serve as the technical lead for process systems in a GMP environment. The role involves managing complex process equipment, leading engineering projects, and ensuring compliance with quality standards. Candidates should have a Bachelor's or Master's in Engineering and 5+ years of relevant experience, particularly in troubleshooting and project leadership. The position is office-based with time on the manufacturing floor and may require some travel.

Qualifications

• Minimum 5+ years of hands-on experience with process equipment/systems.
• At least 4+ years in a GMP manufacturing environment.
• Proven experience leading root cause investigations.

Responsibilities

• Serve as the engineering technical lead for process systems.
• Lead and support CAPEX, OPEX, and continuous improvement projects.
• Drive continuous improvement and optimization of equipment performance.

Skills

Troubleshooting complex technical issues

Experience managing change control

Project leadership

Excellent written and verbal communication skills

Education

Bachelor’s degree in Engineering or Master's degree in Engineering

Professional Engineer (P.E.) license

Job description

We are seeking a highly skilled Senior Engineer, Equipment to serve as the technical lead for process equipment supporting Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems. This role plays a critical part in ensuring equipment reliability, supporting manufacturing operations, and leading engineering projects from concept through implementation.

You will act as a subject matter expert for complex process systems, drive troubleshooting efforts, and lead capital and continuous improvement initiatives in a GMP-regulated environment.

Key Responsibilities

Technical Leadership

• Serve as the engineering technical lead for process systems including:
• Bioreactors, centrifuges, chromatography skids/columns
• Prep and hold tanks, CIP/SIP systems
• Filling and packaging equipment
• Troubleshoot equipment and process issues from qualification through system release
• Perform technical analysis including capacity planning, equipment utilization, and technology assessments
• Support sustainable design, value engineering, and implementation of new technologies

Project Management

• Lead and support CAPEX, OPEX, and continuous improvement (CI) projects
• Develop and review project execution plans and resource estimates
• Own risk assessments for new and existing systems
• Manage commissioning and startup activities, including:
• Approval of commissioning reports and protocols
• SOP development and review
• Provide technical oversight of contractors and project teams

Optimization & Compliance

• Drive continuous improvement and optimization of equipment performance
• Ensure compliance with GMP, quality, and EHS standards
• Lead or support deviation investigations, CAPA, change control, and risk assessments
• Act as System Owner when required (e.g., deviations, out‑of‑tolerance events)
• Contribute to the development and implementation of engineering standards and best practices
• Participate in cross‑functional and peer reviews
• Collaborate with global engineering teams to standardize processes and documentation

Qualifications

Required Experience & Skills

• Minimum 5+ years of hands‑on experience with process equipment/systems
• At least 4+ years in a GMP manufacturing environment
• Strong expertise in troubleshooting complex technical issues
• Proven experience leading:
• Root cause investigations
• Equipment commissioning and qualification
• Experience managing change control, deviations, and CAPA processes
• Demonstrated project leadership (CAPEX or continuous improvement initiatives)
• Ability to manage contractors and cross‑functional stakeholders
• Excellent written and verbal communication skills

Education

• Bachelor’s degree in Engineering with 5–10 years of relevant experience, OR
• Master’s degree in Engineering with 5+ years of experience, OR
• Professional Engineer (P.E.) license

Work Environment & Additional Requirements

• Primarily office‑based with regular presence on the manufacturing floor
• Ability to work in a regulated (GMP) environment
• Occasional domestic and international travel may be required
• Must be able to meet standard visual and physical job requirements

What You’ll Bring

• Strong ability to manage competing priorities in a fast‑paced environment
• Collaborative mindset with experience working across functions (Manufacturing, Quality, Supply Chain, IT, etc.)
• Commitment to safety, compliance, and operational excellence