Project Engineer, Process Engineer

Latest job information from Sigma Systems, Inc. for the position of Project Engineer. If the Project Engineer vacancy in Fremont matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Sigma Systems, Inc. for the position of Project Engineer below matches your qualifications.

Project Engineer Fremont, CA 6 Months

Sigma Inc. is currently looking for a Project Engineer.

• The Senior Engineer, Equipment is the Engineering technical lead on the 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, and support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
• May also own change control and participate in deviation/risk assessment activities.
• Manage medium‑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.

• Experience and knowledge with process systems and equipment in bioreactors, centrifuges, chromatography skids and columns, prep and hold tanks, CIP/SIP, filling and packaging equipment.
• Expert knowledge of processes, automation and process‑specific technology to participate in troubleshooting as the engineering technical lead.
• Technical analysis including 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 approver of protocols and periodic monitoring.
• Lead/manage project team including overseeing and providing guidance on contractors’ activities.
• Provide estimates of resource requirements.

• Own technical optimization of the field of care.
• Ensure that facility equipment, machinery, documentation and technical support meet compliance, quality and EHS standards.
• Lead and motivate activities to ensure continuous optimization.
• Lead/execute CAPA, deviation, change control and risk assessment (quality, business and/or safety).
• Lead implementation and improvement of best practice of technical standards and procedures.
• Act as a member of Global Engineering Biopharmaceuticals and of global Engineering Boehringer Ingelheim.
• Participate in peer‑to‑peer reviews as needed.

• Regulatory requirement per GMP, OSHA and FDA.
• 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.
• Attendance/schedule – attendance requirements are based on general attendance policies and the needs of the business as set forth by the direct manager.

• Bachelor’s in Engineering, 5‑10 years of related field experience.
• 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.
• Excellent oral and written communication skills.
• Minimum 5 years and hands‑on experience with process system/equipment.
• Capable of owning and leading risk assessment, root cause investigation, project startup/commissioning/qualification.
• Expert on troubleshooting technical issues.
• Owner of change control, deviation and CAPA.
• Capable of leading projects (CAPEX or CI).
• Oversee contractor(s) and provide guidance/approval on activities at site.
• Knowledge of GMP compliance.
• Technical expertise on process equipment/system.
• Recognize safety requirements in manufacturing environment.
• Equipment hands‑on experience.
• Project leadership experience.

• Company: Sigma Systems, Inc.
• Work Location: Fremont
• Country: US