Packaging Engineer
Company: Civica Rx
Location: Petersburg
Posted on: January 26, 2023
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Job Description:
About Civica
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. Civica
is led by an experienced team of healthcare and pharmaceutical
industry leaders.
Today, more than 55 health systems have joined Civica. They
represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit
called CivicaScript, to into the outpatient pharmacy space and to
manufacture and distribute insulins that, once approved, will be
available to people with diabetes at significantly lower prices
than insulins currently on the market. The availability of Civica's
affordable insulins, beginning in 2024, will benefit people with
diabetes who have been forced to choose between life sustaining
medicines and living expenses, particularly those uninsured or
underinsured who often pay the most out of pocket for their
medications.
Civica's mission is to ensure that quality generic medications are
accessible and affordable to everyone. Since established, the #1
Policy for the Civica team has been Do What Is in the Best Interest
of Patients. Civica's manufacturing facility in Petersburg,
Virginia, is the future home of affordable insulin and essential
sterile injectable medicines. The facility is currently in
late-stage construction and hiring for the site is
well-underway.
To find out more about how Civica's innovative model is directly
impacting patient care, click here to read a summary from the New
England Journal of Medicine.
https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189
To learn more about Civica's plans to bring affordable insulin to
Americans living with diabetes, click here to read an article in
BioSpace.
Position Summary
The Packaging Engineer 's primary responsibilities are to create
packaging component specifications, BOMs, and complete the required
testing to support Civica's manufacturing facilities, PLD business,
and CivicaScript. The successful candidate will routinely interface
with outside vendors, Manufacturing, Quality, Engineering, and
Supply Chain.
Essential Duties and Responsibilities
Create specifications for primary, secondary, and tertiary
packaging components
Create bill of materials to define packaging configurations for
each product
Write SOPs to define procedures for areas of responsibility
Coordinate ISTA/ASTM test procedures for packaging components and
configurations
Write technical documents such as engineering standards, DOEs, and
risk assessments
Assist with equipment project deliverables from RFQ through FAT
including inspection, device assembly, and packaging equipment
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 areas of responsibility as per change control
procedures
Minimum Qualifications (Knowledge, Skills, and Abilities)
Exposure to parenteral packaging preferred
Strong interpersonal and communication skills, both written and
verbal
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
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 cross-functional teams to execute activities
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. Demonstrated excellence in planning and
organizational skills
PI201562088
Keywords: Civica Rx, Richmond , Packaging Engineer, Engineering , Petersburg, Virginia
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