Engineering Specialist - Operations - Civica Rx
Petersburg, VA 23806
About the Job
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
Position Summary
The Engineering Specialist, Operations will play a part in the facility start up with primary responsibilities focused around supporting daily engineering operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. In collaboration with stakeholders, this position will support cross-functional teams with equipment qualifications, change management, investigations, SOP revisions, training, metrics and development. The ideal candidate will have a consistent track record of achieving results in a face-paced manufacturing environment.
Essential Duties and Responsibilities
- Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.
- Support onboarding and technical training of Engineering personnel on Facilities, Utilities, Manufacturing and Packaging equipment.
- Initiate and complete engineering related investigations including data gathering, reports, root cause analysis, product impact assessment and, leading cross-functional meetings with involved parties.
- Assist in the creation, revision, and management of engineering documents such as technical reports and SOPs.
- Provide technical expertise and support to engineering teams, by managing Change Controls and CAPA's.
- Supports regulatory inspections.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.
- Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration.
Basic Qualifications (Knowledge, skills, and abilities)
- Associate's degree in Pharmaceutical Sciences, Engineering or related field preferred.
- A minimum of four years' experience in Sterile Injectables, Biopharmaceutical or Pharmaceutical manufacturing in a GMP environment.
- Experience with sterile fill finish manufacturing.
- Detailed-oriented with a focus on accuracy in creating and updating engineering documents.
- Experience in using ERP systems.
- Knowledge of GMP, regulatory requirements, and industry best practices.
- Strong communication and collaboration skills, with a commitment to meeting high-quality standards. Strong writing and documentation skills.
- Experience in a process improvement environment, including change management, optimizing process flow and participating in Lean/Six Sigma project teams.
- Self-directed with effective analytical and problem-solving skills preferred.
- Interact with other functions and must be able to take ownership of and follow through on assigned projects.
Preferred Qualifications
- Knowledge of clean utilities, plant utilities, metrology, high speed pen assembly, high-speed aseptic filling, autoclaves, and isolators among others.