Baxter International
Hayward, CA
Shift: Full time
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Summary The Senior Maintenance/Facilities Engineer is a key site operations representative responsible for completing tasks which support the day-to-day operations and deliverables to the business. The Engineer supports facilities and maintenance operations, designing, maintaining, and optimizing plant critical systems, manufacturing equipment, and critical utilities to ensure safety, reliability, and efficiency. Conducts engineering studies and process improvements to support process validations and contribute to maximizing production equipment performance. Provides engineering support for production equipment, troubleshooting, and process validation of new and existing products, equipment, and utilities. Performs capital project planning, justification, specification development, and budgeting, with oversight. Manages vendor interactions, equipment specifications/design, concepts, and vendor negotiations. The position supports the sustaining of production equipment, utilities, and processes in a state of control and compliance through the planning, execution and implementation of process validation and controls to meet regulatory agency 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 Provide technical hands-on support and continuous improvement efforts for production equipment, automation, infrastructure, utilities and capital projects Will act as one of the main contacts for management/maintenance of Critical Systems, Infrastructure and Process Equipment Provide Engineering support to the Manufacturing and Maintenance groups to troubleshoot and improve/maximize the performance of equipment and processes Maintain documentation associated with manufacturing equipment and processes. 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 methodologies and failure mode analyses. Partner with Manufacturing to develop lean principles to implement solutions for equipment, process, and/or utilities issues. Conduct and coordinate development of procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Commissioning, Qualification and Validation activities. Application of statistical tools like Minitab to perform statistical analysis using tools such as SPC, SQC and DOE, preferred. Ensure a safe work environment is maintained through adherence to safety guidelines and policies and ensure compliance with CA state and federal EPA regulation and laws. Complete EHS/Safety activities for Benchmark ATS and Hazard ID actions. Ensure all mandatory training requirements are met, including EHS training, GMP refresher training and any applicable training requirements for all employees. Qualifications Excellent problem-solving, organizational, analytical and critical thinking skills. 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 (cGDP), be self-motivated and possess strong interpersonal skills. Ability to identify, define, and solve complex problems using a data-driven problem-solving approach (i.e.
). Ability to author and execute engineering test and validation protocols for manufacturing processes, equipment, and utilities, including analysis, recommendations, and reporting. Must be able to update procedures and modify processes to simply complexity and improve efficiency. Must be able to present project overviews and other departmental presentations. Education and/or Experience Bachelor’s degree of Science in Mechanical, Biomedical, or Electrical Engineering, or similar field. 3-5 years of experience in the Maintenance/Facilities/Engineering field in a Pharmaceutical or Medical Device Manufacturing Industry, preferre