: Engineer (JP8048)
Thousand Oaks, CA
: 24 months with likely extensions
Job posting date
Note: Onsite Essential
3 Key Consulting is hiring a Engineer
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- 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
- 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
Employee Value Proposition:
- 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
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.
- 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
First interview by phone
Second interview via Webex with engineering group.
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.