Engineer, Facilities, Equipment and Analytical support (JP12166)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Facilities, Equipment and Analytical
support (JP12166) Location: Thousand Oaks, CA. 91320 Business Unit:
F&E Drug Substance Supply Employment Type: Contract Duration: 1
year(s) (with possible extensions) Rate : $38 - $42/hour W2 Posting
Date: 01/12/2024 Notes: Only qualified candidates need apply. Fully
onsite. 3 Key Consulting is recruiting an Engineer, Facilities,
Equipment and Analytical Support for a consulting engagement with
our direct client, a leading global biotechnology company. Job
Description: This engineering position supports manufacturing
activities associated with cGMP equipment and facilities at clients
site in Thousand Oaks. The engineer will lead activities in
alignment with clients’s Commissioning and Qualification Process
(CQP) to ensure that new GMP equipment is installed and maintained
in a validated state. This role will collaborate with the
maintenance, project management, the engineering technical lead,
and manufacturing to develop and oversee the implementation,
operation and reliability of equipment. The engineer will work
closely with Quality Assurance (QA) to ensure GMP compliance and
address potential gaps. In addition, the engineer will evaluate
equipment maintenance plans, support periodic review of
manufacturing systems, and investigate root causes of equipment
issues. The engineer will support the projects in defining
strategies for quality systems verification and will work with the
process development / validation team to develop and document
appropriate practices for characterization. Top Must Have Skill
Sets: Fundamental client Leadership and Values -preferable to see
former client worker Good Communication / Safety / Quality Focused
Fundamental Technical Knowledge. Person will be working in a
manufacturing environment but in this posting, we are looking for
an engineer with strong ANALYTICAL skills and background Day to Day
Responsibilities: The engineer will lead activities in alignment
with client’s Commissioning and Qualification Process (CQP) to
ensure that new GMP equipment is installed and maintained in a
validated state. This role will collaborate with the maintenance,
project management, the engineering technical lead, and
manufacturing to develop and oversee the implementation, operation
and reliability of equipment. The engineer will work closely with
Quality Assurance (QA) to ensure GMP compliance and address
potential gaps. In addition, the engineer will evaluate equipment
maintenance plans, support periodic review of manufacturing
systems, and investigate root causes of equipment issues. The
engineer will support the projects in defining strategies for
quality systems verification and will work with the process
development / validation team to develop and document appropriate
practices for characterization. The Engineer role will provide
direct engineering technical support as follows: Be individually
accountable for the verification deliverables on key capital
projects. Assist in the identification of critical quality
parameters and process attributes for new equipment or facility
modifications. Oversee development of validation protocols in line
with CQP and cGMP standards. Lead, evaluate, and manage performance
of contract resources. Provide oversight for verification
deliverables developed by outsourced/contract verification staff.
Act as a liaison between Engineering, Manufacturing, and Quality
Assurance during project planning, execution, and closeout. Ensure
that validation protocols are executed and documented in accordance
with cGMP good documentation and safety compliant practices. Ensure
safety during commissioning, validation, maintenance, and
manufacturing activities. Review and approve the commissioning
report and ensure that all validation exceptions have been
adequately addressed. Conduct and document periodic equipment
validation reviews. Perform equipment troubleshooting and root
cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
Related Activities: Participate or lead, when required,
multidisciplinary site teams, e.g. Cross Functional Team, Root
Cause Analysis lead. 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 Provide coaching and guidance to
project teams and engineers on the CQP process and risk-based
approaches to commissioning and verification Defend the
equipment-specific calibration, maintenance, & validation as
required during regulatory inspections Participate in internal
audits and assess risks in conjunction with QA. Assist in
developing and maintaining metrics related to equipment performance
Provide technical expertise to develop reliability improvement plan
including design requirements, maintenance strategy, spare part
procurement. Lead improvement implementation plans while following
safety requirements Assist with equipment maintenance and
troubleshooting during project duration Introduce and implement new
analytical systems to improve reliability when needed. Lead
implementation plan to ensure new systems are implemented per
client’s requirement. Contact vendors as needed to understand and
assess any change impact (to equip, utility, facility) as
improvements are planned and executed. Develop GMP documentation
following good documentation practices including validation plans
and standard operating procedures. 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 Preferred Qualifications: Bachelor's degree in
engineering or another science-related field 2 years of relevant
work 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
Experience implementing risk-based verification on major GMP
process equipment / automation projects, including validation
protocol development and execution Demonstrated strong
communication and technical writing skills Strengths in
facilitation and collaboration / networking with cross-functional
groups 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 Proven track record of applying process improvement
methodologies to mature and improve business processes (e.g. PDCA,
LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Problem solving skills using scientific and engineering methods and
investigative skills for root cause analysis. Availability to
support outside regular hours as needed Demonstrate skills in the
following areas: Problem solving and applied engineering. Basic
technical presentations. Personal organization. Adapting to and
managing change. Project and document management systems (CDOCS,
E-Builder, PCS, BMS and QEMS). Validated GMP management systems
(Maximo CMMS, Trackwise) Project management and cost development
Conflict Resolution Leadership and team building Red Flags: Safety
not recognized as top priority Poor communication Has issues under
stressful situations Blames other for negative situations Interview
Process: One phone and one virtual panel 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, Rancho Palos Verdes , Engineer, Facilities, Equipment and Analytical support (JP12166), Engineering , Thousand Oaks, California
