Job Title: Senior Engineer, Pharma Equipment/Facilities Management (JP12841) Location: Thousand Oaks, CA. 91320 Business Unit: F&E Drug Substance Supply Employment Type: Contract Duration: 6+ months with possible extension or conversion to FTE Rate: $45 - $50 / hr. Posting Date: 06/10/2024. Notes: Fully onsite must be local, not looking for relocation job seekers. Standard business hours, some possibility for OVT
3 Key Consulting is recruiting a SeniorEngineer for a consulting engagement with our direct client, a leading global Pharma company.
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.
Job Description: This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks, CA. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
The Engineer role will provide direct engineering technical support as follows:
Be individually accountable for the verification deliverables
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
Assist in development and review of User Requirements Specifications (URS).
Suggest design modifications to address risks and design in quality and safety.
Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout
Ensure safety during commissioning, validation, maintenance and manufacturing activities
Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Responsible for equipment troubleshooting in a timely manner.
Identifying reliability improvements for assigned equipment to improve equipment uptime.
Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Provide ad hoc technical support and guidance for manufacturing and maintenance
Provide concise and clear documentation for actions taken on systems
Demonstrated skills in the following areas:
Problem solving and applied engineering.
Basic technical report writing and presentations
Verbal communication
Personal Organization
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
Specialized equipment/process expertise
Ability to handle multiple projects at the same time
Schedule development, facilitation and collaboration
Basic project management, project completion and follow-up
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Negotiation, persuasion and facilitation Collaboration
Project Cost development
Conflict Resolution
Customer service in a technical setting
Management of contractors and vendors.
Flexibility to work off-hours and fully on-site
Basic Qualifications: Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience
Top Must Have Skill Sets:
Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
Team work experience
Pharmaceutical equipment management background
Employee Value Proposition: Possible FT opportunity if goes well, contract will continue past current end date if things are going well (the business need will be there)
Red Flags: No work experience No engineering or technical experience No collaboration experience No work gap of more than 3 months
Interview Process: WebEx interview with a panel of 1-3.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.