About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for an experienced Automation Engineer to serve as the working automation controls SME to support the overall efforts of selecting, installing, and qualifying (FAT, SAT, commissioning, IQ, OQ, PQ) the equipment and systems of a GMP sterile injectables manufacturing plant.

Primary Responsibilities

• Maintain OEM control systems for various plant and production equipment
• Integrate OEM systems into plant Control System Network which may include database creation and qualification.
• Draft standard operating procedures in alignment with manufacturing compliance requirements.
• Draft design specs and operational qualifications.
• Design, build, and qualify network infrastructure in a GMP compliant manner.
• Generate test scripts to allow for successful IQ/OQ execution.
• Serve as liaison between Engineering and Validations.
• Maintain systems to comply with CFR 21 Part 11 requirements.
• Implementation of SCADA networked platform for initial design, and further enhancements to include additional equipment/processes.
• Setup data historian to allow system queries for Alarms/Events, and reporting platform for batch reporting trending and audit trail capability.
• Design, implement, and qualify PLC/HMI/SCADA design changes in a compliant manner.
• Support Process Automation aspects of CAPA investigations.
• Diagnose and repair process equipment and building automation systems.

Additional Responsibilities

• Performs other related duties and assignments as required.

Qualifications

• 6+ years of experience working as a Process Controls & Automation Engineer/Technician (or similar role) in a GMP manufacturing environment.
• Life Science, GMP experience required (Pharma preferred, though Medical Device experience will be considered).
• Proficiency with PLC applications including Allen Bradley Factory talk Logix RSLogix 5,500, 5000.
• Proficiency with HMI applications including Rockwell Factory Talk View, PanelBuilder.
• Proficiency with SCADA applications including Rockwell Factory Talk SE.
• Proficiency with Data Acquisition systems including Yokogawa and Kaye.
• Proficiency with Data Historians including OSI PI and ihistorian.
• Proficiency with Relational Databases including SQL Server.
• Self-motivated, proactive, detail oriented and able to manage multiple tasks while still meeting deadlines.
• Have a work ethic that brings a positive, customer-centric approach to your work.
• Able to work without reasonable supervision.
• Team oriented.
• Ability to work afterhours and weekends when required.
• Proficiency with Microsoft Office applications.
• Great organizational skills and ability to prioritize tasks.
• Onsite 5 Days/Week required.
• Travel to Germany 1-2 times a year (for 1-2 weeks per trip) is needed.
• Valid Driver’s License will be required.

Education & Certifications

• Associate Degree in Electrical Engineering with Process Controls emphasis.
• Additional relevant education and certifications is a plus.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.