Automation Engineer 2nd Shift (514)
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description

Civica is searching for an Automation Engineer on the second shift with experience in pharmaceutical drug product manufacturing. The Petersburg site serves as Civica's new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.

As a member of the Engineering Team, the successful candidate will be required to support system automation initiatives and perform troubleshooting that requires a good understanding of analytical problem-solving techniques, project management, lifecycle management, network, and virtual environments. The position requires a good understanding of programming, design, installation, and lifecycle management of manufacturing process controls, packaging equipment, aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.

Essential Duties and Responsibilities:

We are seeking a skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer, your job responsibilities include:

• Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell's FactoryTalk View Systems.
• Trouble-shoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI)
• Support Rockwell's Data Historian, AssetCentre, FactoryTalk Directory, etc.
• Troubleshoot day-to-day issues and provide guidance to junior engineers.
• Good understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.
• Development of detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
• Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.
• Independent, self-motivated, organized, able to multi-task in a dynamic environment and embrace a team-based culture that relies on collaboration for effective decision-making.
• Support ownership and administration of process control automation in a GMP-regulated environment.
• Generate and follow proper change control for any automation/process changes within the system.
• Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
• Support new product introductions or new technology introductions by performing engineering assessments, engineering studies, implementing automation system configuration changes, and supporting engineering runs.
• Design and testing of newly installed and currently installed automation-based process and packaging equipment.
• Assist in the support of network advancements and new technologies as they pertain to networking architectures.

• Master's degree and 2 years of Engineering/Automation experience or bachelor's degree & 4 years of Engineering/Automation experience or associate degree and 6+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering)
• Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
• Knowledge and understanding of Data Integrity and how it applies to the Pharmaceutical Industry with a specific focus on guidelines from the FDA.
• Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.
• Knowledge of systems such as Allen Bradley PLC platforms (ControlLogix and CompactLogix) Studio 5000 software.
• Knowledge of Siemens PLCs and software (TIA Portal software)
• Knowledge of FactoryTalk Directory, FactoryTalk AssetCentre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.
• Experience working with virtual environments. (ESXI version 7.0, VMware Workstation, Virtual Network Configuration).

• Experience in sterile fill-finish facility manufacturing.
• Experience with regulatory inspections.
• Programming Switches, Firewalls, and designing networking architecture is preferred.
• ThinManager/Thin Clients, SQL Server design, implementation, and support.
• Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC and Wastewater systems.