Process Engineer, Pharmaceutical
Company: Civica Rx
Posted on: January 16, 2022
Over the past two decades, shortages of generic, injectable
medications critical to the lifesaving work of hospitals in the
United States have become commonplace. Approximately 200 medically
necessary drugs are on the U.S. Food and Drug Administration's
shortage list. Manufacturing challenges and predatory pricing are
both the cause and result.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in
2018 by health systems and philanthropies to reduce chronic generic
drug shortages and related high prices in the United States. Led by
an experienced team of health care and pharmaceutical industry
Today, more than 50 health systems have joined Civica. They
represent over 1,200 hospitals and over 30 percent of all U.S.
hospital beds. Civica has also begun to supply the U.S. Department
of Veteran's Affairs, the U.S. Department of Defense, and the U.S.
Strategic National Stockpile of essential medicines.
Civica is improving patient outcomes and reducing healthcare costs
by making strides to ensure patients and their needs come first and
that essential generic medications are accessible and affordable.
Since established, the #1 Policy for the Civica team has been "Do
What Is in the Best Interest of Patients."
Civica is launching a subsidiary to enter the Outpatient pharmacy
market partnering with Blue Cross Blue Shield with the goal of
reducing drug prices, especially high-cost generic drugs where
market forces are not working to control drug costs.
To find out more about how Civica's innovative model is directly
impacting patient care, to read a recent article from the New
England Journal of Medicine.
Intro to Civica
This Process Engineer is an integral part of the creation of
aseptic filling and supporting operations at Civica's first
manufacturing facility in Petersburg, Virginia. Key duties include
coordinating equipment vendor activities through design,
fabrication, installation, and qualification; and serving as
front-line technical support to Manufacturing. The successful
candidate will routinely interface with outside vendors,
Manufacturing, Quality, Engineering, and Supply Chain.
Essential Duties and Responsibilities
- Management of equipment vendors including the execution of FAT
& SAT, on-site maintenance visits, management of continuous
improvement projects & spare parts criticality
- Support execution of the Commissioning & Qualification
activities for responsible equipment (e.g. filler, isolator/VHP,
packaging equipment, component prep, critical utility systems)
including FAT, Commissioning, SAT, IQ and OQ.
- Responsible for delivering cycle development for relevant
processes and preparation of required cGMP documentation for
- Coordinate technical deliverables across all business functions
to support successful processes and product launches.
- Lead and participate in cross-functional teams to troubleshoot
and resolve technical issues, drive continuous improvement, and
process optimization using tools such as DMAIC and FMEA.
- Manage changes for responsible equipment as per site change
- Participate in regulatory inspections (e.g. FDA, DEA
- Lead improvement of equipment reliability through CI and TPM
processes to support the transition from project level to
sustainable manufacturing/ramp up production.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Exposure to parenteral processing equipment and operations
including formulation, filling, visual inspection, and packaging
- Strong interpersonal and communication skills, both written and
- Project management experience.
- Ability to work effectively with outside suppliers.
- Knowledge of C4I and LEAN methodologies.
- Strong problem-solving skills.
- Strong mechanical aptitude and hands-on approach.
- Familiarity with engineering and architectural/construction
drawings highly advantageous.
- Demonstrated ability and willingness to accept ownership of new
technical challenges and assigned projects.
- Passion for Civica's mission to provide affordable quality
generic medicines that are accessible to all.
Education and Experience
- B.S. in Engineering or Science discipline required.
- Experience working in a cGMP environment preferred.
- Ability to manage teams to execute activities on the
- Experience in data-driven approach to root cause analysis and
prioritization of continuous improvement initiatives (e.g., Six
Sigma, 5-why, fishbone diagram).
- Ability to adapt to changing priorities as project demands and
business needs change.
- CQV experience and greenfield facility start up experience
- Ability to explain complex technical issues to external
- Demonstrated excellence in planning and organizational
Physical Demands and Work Environment
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this position. Reasonable accommodations may
be made to enable individuals with disabilities to perform the
functions. While performing the duties of this position, the
employee is regularly required to talk and hear. The employee
frequently is required to use hands or fingers, handle or feel
objects, tools, or controls. The employee is occasionally required
to stand; walk; sit; and reach with hands and arms. The employee
must occasionally lift and/or move up to 25 pounds. Specific vision
abilities required by this position include close vision, distance
vision, and the ability to adjust focus. The noise level in the
work environment is usually low to moderate.
Keywords: Civica Rx, Richmond , Process Engineer, Pharmaceutical, Engineering , Petersburg, Virginia
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