Engineer - Metrology (331) - Civica Rx

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

The Engineer will develop, manage, and maintain the Metrology Program for Civica’s Petersburg Pharmaceutical Manufacturing facility. You have a willingness to perform "hands-on" work in a dynamic, fast-paced start up environment. Incumbent provides technical expertise on metrology and compliance standards.

Essential Duties and Responsibilities:

• Create and modify calibration procedures by determining metrology requirements such as calibration test points, tolerances, etc. from manufacturer’s manuals, laboratory methods, or system requirements.
• Determine calibration requirements and frequency based on intended use.
• Recommend, acquire, and set up appropriate calibration standards.
• Perform as Subject Mater Expert for calibrations, troubleshooting, and audits.
• Perform and document calibration failures investigations.
• Author metrology change controls and perform impact assessments as required.
• Perform calibrations and measurements traceable to NIST, the International System of Units (SI) using appropriate reference standards. Test and measurement equipment range from general-purpose physical and dimensional equipment to custom built sterilizer systems. Disciplines comprise: Mass, Temperature, Humidity, Vacuum, Length, Optics, Pressure, Dimensional Metrology, Force, and Flow.
• Enter calibration results in Civca’s selected CMMS.
• Work with data acquisition and validation equipment, (e.g. process control equipment/controllers, chart recorders, DC Analog/Signal Conditioners, and transducers).
• Troubleshoot, inspect, and repair test and measurement equipment in support of new projects.
• Work with equipment users, engineers, and other technicians in the proper operation and selection of test and measurement equipment.
• Provide on-site calibration support for equipment that is either too sensitive to move or is too large and not feasible to relocate.
• Work overtime when necessary to support high priority requests or meet project goals.
• Perform or supervise preventative maintenance tasks related to calibration activities.
• Ensure manufacturing and laboratory personnel are supported to meet business needs, including lab gases, preventive maintenance, equipment service contracts and safety equipment.
• Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
• Able to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gases, steam, and moving machinery.
• Able to check and respond to and troubleshoot Equipment Monitoring System (EMS) & Building Management Systems issues and alarms.

Basic Qualifications and Capabilities:

• Minimum of 8 years of relevant experience and technical education or certification in addition to prior work experience.
• Associate degree in technical discipline or equivalent.
• The ability to determine calibration requirements and frequency based on intended use.
• Ability and experience with CCMS such as Blue Mountain, reading schematics, wiring diagrams & other technical documents. 

Preferred Qualifications:

• Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.
• Strong investigation writing skills.
• Experience with regulatory inspections.
• Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.