Project Engineer III

Duties

• 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).

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.
• 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.