Project Engineer III

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.
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 ***.
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


Skills:


Knowledge of GMP compliance
Technical expertise on process equipment/system
Recognize safety requirements in manufacturing environment
Equipment hands on experience
Project leadership experience
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