Job Title: Project Engineer III
Location: Fremont, CA
Type: Contract
Compensation: $90-100/hr
Contractor Work Model: Onsite
Hours: 40.0


Overview
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.


Responsibilities

• Serve as the Engineering technical lead for Bulk Drug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems. This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
• Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
• Might also own change control and participate in deviation/risk assessment activities.
• Manage medium in size and complexity equipment related projects.
• Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
• Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.
• Technical Analysis: including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.
• Lead/participate in CAPEX/OPEX/CI projects.
• Own risk assessment for new systems and changes to existing systems.
• Write/review project execution plans.
• Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...)
• Technical approvers of protocols and periodic monitoring.
• Lead/manage project team including overseeing & providing guidance on contractors activities.
• Provides estimates of resource requirements.
• Own technical optimization of the field of care.
• Ensures that the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards.
• Leads/motivates activities to ensure a continuous optimization process.
• Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety).
• Leads implementation and improvement of best practice of technical standards, procedures.
• Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering.
• Participates in peer-to-peer reviews as needed.
• Collaborate with internal cross functional groups - Mfg, SCM, Quality, CMO, Finance, IT.
• Work closely with external contingency worker, contractors, possible customers, auditor.

• Bachelor’s in Engineering, 5-10 years of related field experience or, Master’s in Engineering, +5 years’ of related field experience or P.E. License.
• Minimum of 4 years’ working experience in a GMP manufacturing environment.
• Minimum 5 years and hands on experience with process system/equipment.
• Regulatory requirement per GMP, OSHA and FDA.
• Knowledge of GMP compliance.
• Technical expertise on process equipment/system.
• Recognize safety requirements in manufacturing environment.
• Equipment hands on experience.
• Project leadership experience.
• Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
• Expert on troubleshooting technical issues.
• Owner of change control, deviation and CAPA.
• Capable to lead projects (CAPEX or CI).
• Capable of balance conflicting priorities and agile to manage changing priorities.
• Ability to establish highly functional relationships with diverse personalities.
• Physical demands/surroundings - work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile.
• Some domestic and international travel may be required.
• Visual Demands - must be able to read and see clearly with or without correction lenses.
• Excellent oral and written communication skills.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality.

System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
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.