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. DMAIC).

• 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, preferred.

• Experience with statistical analysis, preferred.
• Green Belt, Black Belt, or PMP certification, preferred.

Physical Demands & Working Environment

• Climbing – Ascending or descending ladders, stairs, scaffolding, and ramps. Standing – Particularly for sustained periods of time.
• Walking – Moving about on foot to accomplish tasks, moving from one building to another.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: