Senior Process Engineer - Biopharmaceutical Equipment

Responsibilities:

• Excellent employment opportunity for a Project Engineer III in the Fremont, CA area.
• 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, 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.

Technical Expertise

• Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipment
• 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.

Project Management

• 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

Optimization & Compliance

• 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)

Global Engineering

• Leads implementation and improvement of best practice of technical standards, procedures.
• Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering Boehringer Ingelheim.
• Participates in peer-to-peer reviews as needed.

Regulatory and/or Organizational Requirements:

• 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 direct manager.

Job Complexity:

• Capable to balance conflicting priorities and agile to manage changing priorities
• Ability to establish highly functional relationships with diverse personalities
• Internal cross functional groups - Mfg, SCM, Quality, CMO, Finance, IT
• External contingency worker, contractors, possible customers, auditor

Experience:

• 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
• Excellent oral and written communication skills
• Minimum 5 years and hands on experience with process system/equipment
• 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)
• 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