Project Engineer III

Job Title:

Project Engineer III

Location:

Fremont, CA

Type:
Contract

Compensation: $90-100/hr

Contractor Work Model:
Onsite

Hours:

40.0

A leading pharmaceutical company is seeking an experienced Project Engineer III to support engineering initiatives across Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems. The ideal candidate will bring strong technical expertise in GMP manufacturing environments, hands‑on process equipment experience, and proven project leadership capabilities within biopharmaceutical operations.

• Serve as the Engineering technical lead for Bulk Drug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems, including upstream and downstream BDS, filling and packaging equipment.
• Act as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, and support, participate or lead site CAPEX, OPEX, and continuous improvement projects from feasibility study to handover.
• Own change control and participate in deviation and risk assessment activities.
• Manage medium‑sized and complex equipment‑related projects.
• Act as System Owner for process equipment when required.
• Use expert knowledge of processes, automation, and process‑specific technology to troubleshoot as the Engineering technical lead.
• Perform technical analysis—including plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability, and assessment of new technologies—to balance performance, cost, and maintainability.
• Lead or participate in CAPEX, OPEX, and CI projects.
• Own risk assessment for new systems and changes to existing systems.
• Write and review project execution plans.
• Lead and manage startup and commissioning activities (e.g., approve commissioning reports, review and approve TOPs, create, update, or approve SOPs).
• Approve protocols and perform periodic monitoring.
• Lead and manage project teams, including oversight and guidance of contractor activities.
• Provide estimates of resource requirements.
• Own technical optimization initiatives.
• Ensure that equipment, machinery, documentation, and technical support comply with quality, EHS, and regulatory standards.
• Motivate and lead continuous optimization processes.
• Execute CAPA, deviation, change control, and risk assessment (quality, business, and safety).
• Implement improvements to best practice technical standards and procedures.
• Act as a member of Global Engineering Biopharmaceuticals and Global Engineering.
• Participate in peer‑to‑peer reviews as needed.
• Collaborate with internal cross‑functional groups—Manufacturing, SCM, Quality, CMO, Finance, IT.
• Work closely with external contractors, contingency workers, customers, and auditors.

• Bachelor’s in Engineering with 5–10 years of related experience, or Master’s with +5 years, or a P.E. license.
• Minimum 4 years of working experience in a GMP manufacturing environment.
• Minimum 5 years of hands‑on experience with process systems/equipment.
• Knowledge of GMP, OSHA, and FDA regulatory requirements.
• Technical expertise on process equipment and systems.
• Recognize safety requirements in manufacturing environments.
• Hands‑on equipment experience.
• Project leadership experience.
• Capability to own and lead risk assessment, root‑cause investigation, and project startup, commissioning, and qualification.
• Expertise in troubleshooting technical issues.
• Ownership of change control, deviation, and CAPA.
• Capability to lead CAPEX or CI projects.
• Ability to balance conflicting priorities and adapt to changing prioritization.
• Ability to establish functional relationships with diverse personalities.
• Physical demands: work primarily in an office environment but required on the process floor when necessary.
• Domestic and international travel may be required.
• Visual demands: must read and see clearly with or without correction lenses.
• Excellent oral and written communication skills.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.