Senior Engineer, GMP Facilities and Manufacturing Equipment

Location: Irvine, CA (92612)
Company: Baxter
Industry: IT
Job Type: Full Time
Posted: Yesterday

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 patients.

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 healthcare.

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.

Essential Duties and Responsibilities

  • Contribute to continuous improvements in overall product cost and quality.

  • Provide technical support for production tools including assembly equipment and automation.

  • Maintain documentation associated with facilities, maintenance and manufacturing processes.

  • Lead and Collaborate with CAPA and NCR investigation of non-conformances. Identify root cause, corrective action, preventive action, monitoring plan and the overall effectiveness for resolution of CAPA and NCR issues while applying problem-solving methodologies.

  • 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 Cost goals.

  • Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.

  • Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements.

  • 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 processes.

  • 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 of responsibility.

  • 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 projects.

  • 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 existing product/process.

  • 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 systems.

  • 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 manufacturing processes.

  • 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 maintenance activities.

  • Plans, oversees and executes lean energy program initiatives and activities.

  • 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 (ie 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 thinking skills.

  • Advanced knowledge in automated equipment troubleshooting techniques and preventive maintenance methodology.

  • Have good knowledge of mechanical, pneumatic and electrical systems.

  • Proficient in reading and understanding mechanical blueprints and electronic schematics.

  • Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.

  • Proven expertise in Microsoft Office Suite and manufacturing systems.

  • 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 Engineering.

Education and/or Experience

  • Bachelor's degree in Science of Mechanical, Biomedical or Electrical Engineering required.

  • 3 or more years experience working in a GMP environment, preferably medical device or pharma with oversight of automation and manufacturing equipment and facilities equipment.

  • Automation experience with servo motors, pneumatics, robots, PLCs required.

  • Experience in the installation and qualification of new technology.

  • Have proven experience using statistical analysis with tools as Minitab.

  • Green Belt, Black Belt or PMP certification preferred.

  • Knowledgeable in process compressed air, HVAC and RO water systems.

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 ordinary locomotion.

  • 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, or quickly.

  • 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 sound.

  • 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 (ie, custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (ie, security guard, inspection, etc.).

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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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

Reasonable Accommodations

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 .


Web Reference : AJF/378622003-202
Posted Date : Mon, 27 Jun 2022

Please note, to apply for this position you will complete an application form on another website provided by or on behalf of Baxter. Any external website and application process is not under the control or responsibility of IT JobServe

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