Project Engineer

Project Engineer at Tundra Technical Solutions Project Engineer at Tundra Technical Solutions in Newark, California Posted in about 20 hours ago.

Type:

full-time

Job Description:

Senior Engineer, Equipment (Project Engineer III) ???? Fremont, CA (Onsite) ???? 6-Month Contract (High Likelihood of Extension) We are seeking a Senior Engineer, Equipment to serve as the Engineering technical lead supporting Bulk Drug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems within a GMP-regulated manufacturing environment. This role supports upstream and downstream BDS operations as well as filling and packaging equipment, and will act as a key consultant for troubleshooting, system qualification, and project execution from feasibility through handover. Key Responsibilities Technical Expertise Serve as Engineering technical lead for process systems and equipment including: Bioreactors, centrifuges, chromatography skids/columns Prep and hold tanks, CIP/SIP systems Filling and packaging equipment Troubleshoot equipment and process issues through qualification and system release Perform technical analysis including: Equipment utilization and capacity assessments Value engineering and sustainable design Constructability and new technology evaluation Project Management Lead and/or support CAPEX, OPEX, and continuous improvement projects Develop and review project execution plans Own risk assessments for new systems and modifications to existing systems Lead startup and commissioning activities: Approve commissioning reports Review/approve turnover packages (TOPs) Create/review/approve SOPs and protocols Provide resource estimates and manage project timelines, cost, and quality Oversee contractors and provide technical direction on-site Optimization & Compliance Own technical optimization within assigned systems/area Ensure all equipment, documentation, and processes meet GMP, FDA, OSHA, and EHS standards Lead and execute: Deviations, CAPA, change control, and risk assessments (quality, business, safety) Support audit readiness and regulatory inspections Global Engineering Collaboration Contribute to implementation of engineering best practices and standards Participate in peer reviews and global engineering initiatives Support consistent project documentation and execution standards Qualifications & Experience Bachelor's degree in Engineering with 5-10 years of experience, or Master's degree in Engineering with 5+ years of experience, or P.E. license Minimum 4+ years in a GMP manufacturing environment Minimum 5+ years of hands-on experience with process systems/equipment Strong expertise in: Troubleshooting technical issues Root cause analysis and risk assessment Change control, deviation management, and CAPA Commissioning, qualification, and system startup Proven ability to lead CAPEX or continuous improvement projects Additional Details Ability to balance competing priorities in a fast-paced environment Strong collaboration across cross-functional teams (Manufacturing, Quality, Supply Chain, Finance, IT) Experience working with contractors, vendors, auditors, and external partners Primarily office-based with regular presence on the manufacturing floor Some domestic and international travel may be required If you're interested, apply directly and include your resume.