Senior Equipment Engineer

Duties:

• 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.

• 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.

• 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

• Minimum of 4 years' working experience in a GMP manufacturing environment
• 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
• 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