Senior Controls Engineer

Sr. Controls Engineer

The primary function of the Sr. Controls Engineer is to provide technical support of facility Operational Technology (OT) systems, equipment, and controls projects for the new lines 3 and 4 at the Spokane site.

Participate directly or assist others on project teams which are responsible for the design, acquisition, installation, and/or upgrade of critical systems and equipment used in the manufacture of pharmaceutical products.

Responsible for participation in capital and expense projects involving controls in facility or production equipment, cost reduction, process improvement, and/or compliance.

Provide engineering support to manufacturing teams to include process development, process optimization, and deviation investigations.

Provides technical assistance for Spokane OT equipment controls systems.

Provides technical support of OT Controls projects including facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.

Participates in support, guidance, and training for Maintenance controls technicians to include controls system troubleshooting, diagnostics, and repairs.

Provides controls engineering support and guidance for manufacturing teams to include process development, recipe creation and maintenance, and support of related capital projects.

Responsible for acquiring & maintaining knowledge of regulatory requirements for the facility and processes to ensure compliance to local, state, federal and international regulatory agencies.

Manages and/or participates in capital and expense facility projects in a manner that is compliant with the “Project Management Guidelines” system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental team.

Must work effectively with various internal and external customers on a daily basis. Internal customers may include departments such as Maintenance, Quality Assurance, Manufacturing, Validation, Finance, etc. External interactions will include officials from local, state or federal regulatory agencies, A&E firms, construction firms, vendors, equipment manufacturers, etc.

Participates in the compliance to both short/long-term company objectives as defined by management.

Development of detailed specifications and RFQs to be used by A&E firms, contractors or equipment manufactures to accurately quote on projects being pursued by the company.

Responsible for developing and using systems of engineering documentation required by regulatory agencies and in compliance with generally accepted engineering guidelines, SOPs, or quality standards.

Candidate Must Have:

• Bachelor's degree in a related field.
• 10+ years of Controls systems engineering experience.
• Hands-on programming experience with PLC/HMI
• Pharma industry experience working in GMP & FDA
• Experience with GAMP5 – Data Integrity.
• Team spirit, initiative, autonomy, flexibility and creativity.
• Experience with some project management skills, methods and tools

Candidate Nice to Have:

• Bachelor’s degree in computer Science or Engineering – Chemical, Mechanical, Automation
• Advanced degree or PE
• Support and train Jr. Engineers and Maintenance technicians as needed.
• Experience with as many systems listed:
  Rockwell Allen Bradley – PLC using RS Logix, and HMI systems – Panel View, Wonderware, Factory Talk studio suite, Fix
  32, iFix, & Proficy Historian.
• Rockwell Logix Programmer Certification.
• Defining and creating controls solutions such as: defining equipment user interfaces, control logic, alarms and interlocks, security, administration etc.
• MS SQL Server, TCP/IP networking, IDE and DA Servers
• Experience in Equipment commissioning, qualification as well as supporting systems validation.