Senior Project Engineer

We are looking for Senior Project Engineer for our client in

Fremont, CA Job Title:

Senior Project Engineer Job Location:

Fremont, CA Job Type:

Contract Job Overview:

Pay Range:

$95.70hr - $100.70hr Responsible for providing technical leadership and engineering support for Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems within a GMP manufacturing environment. The role focuses on equipment troubleshooting, project execution, process optimization, compliance, and continuous improvement initiatives across biopharmaceutical manufacturing operations.

Requirement/Must Have:

Strong expertise in GMP manufacturing environments. Hands-on experience with process systems and manufacturing equipment. Experience with bioreactors, centrifuges, chromatography skids, columns, CIP/SIP systems, and filling and packaging equipment. Strong troubleshooting and root cause investigation skills. Experience leading CAPEX, OPEX, or continuous improvement projects. Ability to manage change controls, deviations, CAPA, and risk assessments. Strong project leadership and contractor management experience. Knowledge of FDA, OSHA, and GMP compliance requirements. Excellent communication and cross-functional collaboration skills.

Experience:

Minimum 5 years of hands-on experience with process systems and equipment. Minimum 4 years of experience in a GMP manufacturing environment. Experience managing startup, commissioning, qualification, and validation activities. Experience leading engineering projects from feasibility through handover. Experience supporting manufacturing, quality, supply chain, and engineering operations.

Responsibilities:

Serve as the engineering technical lead for BDS, DP, and Process Science systems. Support troubleshooting of process and equipment-related issues. Lead and participate in CAPEX, OPEX, and continuous improvement projects. Manage medium-sized equipment-related engineering projects. Perform system owner responsibilities for process equipment when required. Conduct technical analysis related to equipment utilization, process optimization, and sustainable design. Lead startup, commissioning, qualification, and validation activities. Review and approve protocols, reports, SOPs, and technical documentation. Lead project teams and oversee contractor activities. Support risk assessments, change controls, deviations, and CAPA investigations. Ensure manufacturing systems comply with quality, compliance, and EHS standards. Drive optimization initiatives and process improvements. Participate in global engineering reviews and technical standard improvements. Collaborate with cross-functional teams including Manufacturing, Quality, SCM, Finance, IT, and external partners. Support regulatory inspections and compliance activities.

Should Have:

Experience in biopharmaceutical or pharmaceutical manufacturing environments. Strong analytical and problem-solving skills. Ability to manage changing priorities in fast-paced environments. Experience working with contractors, auditors, and external stakeholders. Domestic or international project support experience preferred.

Skills:

GMP compliance and regulatory knowledge. Process equipment troubleshooting. Risk assessment and root cause analysis. CAPA, deviation, and change control management. Startup, commissioning, and qualification activities. Project leadership and contractor oversight. Process optimization and continuous improvement. Technical documentation and SOP development. Cross-functional collaboration and communication.

Qualification And Education:

Bachelor s degree in Engineering with 5 10 years of related experience, or Master s degree in Engineering with 5+ years of related experience, or Professional Engineer (P.E.) License.