Sr. Engineer, Facilities and Maintenance (2nd Shift)
Location: Mission Viejo
Posted on: January 11, 2022
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your
role at Baxter, your work makes a positive impact on people around
the world. You'll feel a sense of purpose throughout the
organization, as we know our work improves outcomes for millions of
Baxter's products and therapies are found in almost every hospital
worldwide, in clinics and in the home. For over 85 years, we have
pioneered significant medical innovations that transform
Together, we create a place where we are happy, successful and
inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where
your purpose accelerates our mission.
The Senior Facilities & Maintenance Engineer (SFME) is a key site
operations representative. The SFME will be responsible for
completing tasks which support the day to day operations and
deliverables to the business, including design, development,
implementation, and analysis of technical products and systems.
Performs equipment engineering design evaluations. Recommends
alterations to development and design to improve quality of
products and/or procedures. The position supports the sustaining of
production processes in a state of control and compliance through
the planning, execution and implementation of process validation
and controls to meet regulatory agency validation requirements,
internal company standards and current industry practices. Authors
and reviews validation processes and procedures, making
recommendations for changes and/or improvements. This opportunity
is on the 2nd shift Monday through Friday, working 2:30 - 11:00
Essential Duties and Responsibilities
Contribute to continuous improvements in overall product cost and
Provide technical support for production tools including assembly
equipment and automation.
Maintain documentation associated with facilities, maintenance and
Lead and Collaborate with CAPA and NCR investigation of
nonconformances. Identify root cause, corrective action, preventive
action, monitoring plan and the overall effectiveness for
resolution of CAPA and NCR issues while applying problem-solving
Drive execution of CAPA deliverables through monitoring and
reporting status to CAPA Review Board and management in a timely
manner. Ensure compliance to requirements and consistency/quality
of CAPA execution.
Develop, monitor, analyze and improve reliability, lead Root Cause
Failure Analysis (RCFA) and Failure Mode & Effect and Criticality
Assessment (FMECA) efforts.
Partner with Manufacturing to develop lean principals to implement
solutions for product assembly.
Conduct coordinate and aid in formal Process Validations including
protocol development and execution.
Support project team members in achieving business objects related
attainment of Safety, Quality, Service, and Project Schedule and
Follow established procedures to perform detailed, accurate, and
compliant engineering documentation for Master Validation Plans,
PFMEA, Equipment Installation, Characterization, Qualification and
Complete on time project updates, project hours, development plans,
self-assessments, and successful completion of all training
Application of statistical tool like Minitab to perform statistical
analysis using tools such as SPC, SQC and DOE.
Prepare failure analysis reports, concentrating on identifying
repetitive occurrences of failures of critical equipment and
Project management within budgetary and manufacturing/facility
constraints including budgeting of capital and expense dollars for
shop floor support and helping establish long range plans for areas
Ensure all mandatory training requirements are met, including
annual EHS training, GMP refresher training and any applicable
training requirements for all employees.
Provide technical assistance in installation validation and startup
of facilities/production equipment modifications and capital
Develop and execute preventive maintenance procedures and ensures
any PM activities assigned to them are completed by the original
due date or extended if that date cannot be achieved.
Provide training support to the Maintenance group in regard to
troubleshooting and new product/process or modification of an
Provides Engineering support to the Manufacturing and Maintenance
groups to troubleshoot and improve/maximize the performance of
equipment and processes.
Electrical - Troubleshoots automation equipment through PLC (Allen
Bradley and Siemens), Vision Systems (Cognex), servo, robotics
(Denso), HMI/MMI, and related process control and automation
Develop and initiate advanced automated testing methodologies.
Use a combination of testing methods including automated.
Interface with developers in executing projects.
Participate in designing and code reviews.
Mechanical - Prepares standard operating procedures and
troubleshoots mechanical equipment associated with automation and
Manages projects from inception to completion. Keeps Engineering
and Manufacturing Management informed of progress.
Installs, validates and put into production equipment modifications
and capital projects.
Performs hardware/software modifications, and documents system
functional specification updates while adhering to documentation
and change control requirements.
Supports planning and oversight of the execution of year end
Plans, oversees and executes lean energy program initiatives and
Electrical - Prepares standard operating procedures for new and
existing automation and process control equipment.
Ability to identify, define, and solve complex problems using a
data-driven problem-solving approach (i.e. DMAIC).
Developing complex experiments and tests (including writing and
executing protocols) to qualify and validate
manufacturing/facilities processes and equipment; analyze results,
make recommendations, and develop reports.
Excellent problem-solving, organizational, analytical and critical
Advanced knowledge in automated equipment troubleshooting
techniques and preventive maintenance methodology.
Have good knowledge of mechanical, pneumatic and electrical
Proficient in reading and understanding mechanical blueprints and
Effective communication and interpersonal skills at all levels of
employees, suppliers, and consultants.
Proven expertise in Microsoft Office Suite and manufacturing
Must have very strong verbal and written communication skills,
documentation practices (cGDPs), be self-motivated and possess
strong interpersonal skills.
Must be able to update procedures and modify processes to simply
their complexity and improve efficiencies.
Must have the following personal attributes: integrity and trust,
work ethic, sound judgment, intellectual honesty, pragmatism,
courage and conviction.
Must demonstrate the ability to learn new material quickly and
demonstrate high potential for continued professional growth within
Education and/or Experience
Bachelor's degree in Science of Mechanical, Biomedical or
Electrical Engineering required.
3 or more years working experience in the field of Automation and
Equipment Engineering required.
Automation experience with servo motors, pneumatics, robots, PLCs
Experience in the installation and qualification of new
Have proven experience using statistical analysis with tools as
Green Belt, Black Belt or PMP certification preferred.
Knowledgeable in process compressed air, HVAC and RO water
Physical Demands & Working Environment
The physical activity of this position
Climbing. Ascending or descending ladders, stairs, scaffolding,
ramps, poles and the like, using feet and legs and/or hands and
arms. Body agility is emphasized. This factor is important if the
amount and kind of climbing required exceeds that required for
Standing. Particularly for sustained periods of time.
Walking. Moving about on foot to accomplish tasks, particularly for
long distances or moving from one work site to another.
Talking. Expressing or exchanging ideas by means of the spoken
word. Those activities in which they must convey detailed or
important spoken instructions to other workers accurately, loudly,
Hearing. Perceiving the nature of sounds at normal speaking levels
with or without correction. Ability to receive detailed information
through oral communication, and to make the discriminations in
Repetitive motion. Substantial movements (motions) of the wrists,
hands, and/or fingers.
The physical requirements of this position
Medium work. Exerting up to 50 pounds of force occasionally, and/or
up to 30 pounds of force frequently, and/or up to 10 pounds of
force constantly to move objects.
The visual acuity requirements including color, depth perception,
and field vision
The worker is required to have visual acuity to determine the
accuracy, neatness, and thoroughness of the work assigned (i.e.,
custodial, food services, general laborer, etc.) or to make general
observations of facilities or structures (i.e., security guard,
The conditions the worker will be subject to in this position
The worker is subject to hazards. Includes a variety of physical
conditions, such as proximity to moving mechanical parts, moving
vehicles, electrical current, working on scaffolding and high
places, exposure to high heat or exposure to chemicals.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified
applicants without regard to race, color, religion, gender,
national origin, age, sexual orientation, gender identity or
expression, protected veteran status, disability/handicap status or
any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable
accommodations to individuals with disabilities globally. If,
because of a medical condition or disability, you need a reasonable
accommodation for any part of the application or interview process,
please click on the link here and let us know the nature of your
request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where
fraudulent parties pose as Baxter employees, recruiters, or other
agents, and engage with online job seekers in an attempt to steal
personal and/or financial information. To learn how you can protect
yourself, review our Recruitment Fraud Notice.
Keywords: BAXTER, Mission Viejo , Sr. Engineer, Facilities and Maintenance (2nd Shift), Engineering , Mission Viejo, California
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