Manufacturing Engineer (JP12913)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, San Clemente , Manufacturing Engineer (JP12913), Engineering , Thousand Oaks, California
