Sr Maintenance/Facilities Engineer

Baxter International Inc.•Hayward, CA

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits