Senior Engineer, Pharma Equipment/Facilities Management (JP12841)

3 Key Consulting•Thousand Oaks, CA

12d•Onsite

About The Position

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

Requirements

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
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience
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

Responsibilities

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