Our client – a global and growing BioPharma CDMO company needs a Sr. Controls Engineer with Hands-on Controls experience in the Pharma Industry, located at their expanding plant in WA state. Excellent total comp. up to $180K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer.

Job Posting # 2698

Job Title:  Sr. Controls Engineer                                                 

Overnight Travel:  10%                                            

Location:  Spokane, WA                                                                    

Relocation: YES – The client offers a lumpsum bonus for relo assistance.

Compensation: Salary range $125K - $165K + Annual Bonus (Target 10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will support the Controls and Automation systems for the new Aseptic finish fill lines 3 and 4. This role will directly report to the Sr. Manager of Engineering who has around 10 technical staff.

Note 1: The company recently completed their 3^rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4^th line at this growing plant site.

Note 2: The primary Controls hardware is Rockwell Allen Bradley – PLC using RS Logix, and HMI systems like – PanelView, Wonderware, FactoryTalk studio suite, Fix32, iFix, Proficy Historian etc.

Note 3: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will NOT sponsor a new H1B visa application. Contractors who are ready to transfer visa are welcome.

Job Summary:

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. 

Job Description: 

1. Provides technical assistance for Spokane OT equipment controls systems.
2. Provides technical support of OT Controls projects including facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.
3. Participates in support, guidance, and training for Maintenance controls technicians to include controls system troubleshooting, diagnostics, and repairs.
4. Provides controls engineering support and guidance for manufacturing teams to include process development, recipe creation and maintenance, and support of related capital projects.
5. Responsible for acquiring & maintaining knowledge of regulatory requirements for the facility and processes to ensure compliance to local, state, federal and international regulatory agencies.
6. 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.
7. 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.
8. Participates in the compliance to both short/long-term company objectives as defined by management.
9. 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.
10. 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 – PanelView, Wonderware, FactoryTalk studio suite, Fix32, 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.
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization

• Interfacing with OEM equipment vendors, Construction/consulting partners and clients

Keywords: Automation, Controls, PLC, HMI, Project, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, contract Manufacturing, GAMP5