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Engineer (JP8048)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Engineer (JP8048)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 24 months with likely extensions
Job posting date:  1/12/21
Note: Onsite Essential
3 Key Consulting is hiring a Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Provide system ownership for Manufacturing process equipment.
  • Perform the system owner role for assigned systems to ensure equipment reliability and compliance.
  • Specify and oversee preventive maintenance program for analytical equipment.
  • Identify and implement engineering-based improvements or upgrades to the upstream and downstream process equipment including identification of design requirements, options analysis, design, installation, startup, and qualification of equipment.
  • Monitor systems to identify performance risks and implement risk reduction strategies.
  • Role may involve supporting analytical equipment (cell counters, blood gas analyzers, metabolite analyzers, spectrophotometers, filter integrity testers, pH meters, osmometers, particle counters, air samplers, conductivity meters, total organic carbon analyzers).
  • Direct and coordinate equipment maintenance as necessary to ensure systems are in proper working order.
  • Provide troubleshooting support to manufacturing and maintenance staff to reduce production downtime.
  • Support manufacturing operations/training on equipment.
  • Review equipment and administrative SOPs.
  • Lead and/or support technical root cause analysis and implementation of corrective/preventive action.
  • Support change controls for validated equipment.
  • Maintain vendor service contracts.
  • Escort vendor technicians for Preventative/Corrective Maintenance Work orders.
  • Review equipment Preventative Maintenance Plans, ensure spare parts kept within central inventory, etc.
  • Coordinate between Manufacturing, Plant Quality and C&Q groups and interact with auditors as needed.
  • Oversee computerized system periodic reviews.
  • Grant equipment access to new users, perform access audits on computerized equipment.
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and developing new technologies in partnership with Technology Development Team.
  • Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
  • Bachelor’s Degree in science or engineering preferred
Top Must have Skill Sets:
  • Process or analytical equipment experience
  • Bachelor's degree in science or engineering
  • Excellent written and verbal communication
  • Ability to give PowerPoint presentations to small groups and lead technical discussions
Day-To-Day Responsibilities:

  • Daily Work Center Team meetings with Manufacturing and Engineering staff to review equipment status
  • Complete work orders in Maximo to initiate work on equipment by Maintenance staff
  • Troubleshoot issues process or analytical equipment
  • Manage equipment spare parts lists and updates in Maximo
  • Work with a team of engineers and manufacturing staff to support production efforts
  • Make recommendations to optimize facility and equipment
Employee Value Proposition:
Team of 13 engineers working on building 23 commercial and clinical operations. Manages upstream and downstream equipment. There will be a lot of interesting projects.
Red Flags:
  • Unwilling to work onsite in TO full-time during COVID (safe environment and testing provided)
  • Unwilling to work in a clean room Manufacturing environment (certification training provided)
  • Unable or unwilling to wear a mask while onsite
Interview Process:
First interview by phone
Second interview via Webex with engineering group.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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