Job Title:  Manufacturing Engineer (JP12913)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Engineering Drug Substance Supply Group
Employment Type:  Contract
Duration: 5+ months (with likely extensions for 2025)
Rate: $38 - $42 /hour
Posting Date: 6/18/2024.
Notes: Only qualified candidates need apply.  Fully onsite at ATO - no opportunity for remote, Full time onsite support in required.  Standard business hours, some possibility for overtime

3 Key Consulting is hiring!  We are recruiting a Manufacturing Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Looking for industry experience as a manufacturing engineer.  This engineering position supports manufacturing activities associated with manufacturing process equipment at our client’s Thousand Oaks,CA facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:
 

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Be individually accountable for the verification deliverables.
• Assist in the identification of critical quality parameters and process attributes for new equipment.
• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, 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.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• 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.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
• Provide concise and clear documentation for actions taken on systems.

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

Day to Day Responsibilities:
 

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Be individually accountable for the verification deliverables.
• Assist in the identification of critical quality parameters and process attributes for new equipment.
• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, 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.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• 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.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
• Provide concise and clear documentation for actions taken on systems.

Basic Qualifications:

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• 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/troubleshooting 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.
• Project Cost development
• Conflict Resolution
• Customer service in a technical setting
• Management of contractors and vendors.
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Preferred Qualifications:

• Bachelor's degree in engineering-related field
• 5+ years of relevant work experience with 3+ years’ experience in operations/manufacturing

• environment

• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on

• pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production
• facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other

• equipment needed to support these processes such as autoclaves, clean in place (CIP) systems,
• washers, clean steam, etc.

• Process automation knowledge – understanding of automation infrastructure, current technologies,

• and automation project execution / verification.

Why is the Position Open?
Supplement additional workload on team.

Red Flags:

• No work experience
• No engineering or technical experience
• No collaboration experience
• No work gap of more than 3 months

Interview Process:
1-2 VIDEO INTERVIEW

We invite qualified candidates to send your resume to resumes@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.