Aseptic Filling Process Engineer
Company: Civica Rx
Posted on: November 26, 2022
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 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. ( ) To
learn more about Civica's plans to bring affordable insulin to
Americans living with diabetes, click here to read an article in
BioSpace. ( ) Essential Duties
- Management of Equipment Vendors including execution of FAT &
SAT, on-site maintenance visits, management of continuous
improvement projects & spare parts criticality assessments.
- Support execution of the Commissioning & Qualification
activities for new Vial Filling Equipment e.g. filler,
isolator/VHP, glove testers, particle monitoring systems including
FAT, SAT, IQ and OQ.
- Responsible for delivering cycle development for the process
including VHP cycles for Isolator & transport systems and
preparation of required GMP documentation for filling process and
- Coordinate technical deliverables within Filling to support
successful process 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 change in the Vial & Syringe Filling area as per site
change control procedures.
- Support establishment of electronic batch record system for the
- Lead/participate in Standard Work, 5S, TPM, CI & Gemba programs
and daily/weekly tiered manufacturing meetings.
- Participate in regulatory inspections e.g. FDA, DEA
- Support transition from project to sustaining manufacturing and
ramp up of production volumes in future by improving equipment
reliability through CI and TPM processes Required Skills
- Exposure to parenteral processing equipment and operations
including formulation, filling, visual inspection, and packaging
- Exposure or Front-line support to aseptic filling lines.
- Demonstrated ability to solve technical problems and implement
- Strong interpersonal and communication skills.
- Project management experience.
- Ability to work effectively with outside suppliers.
- Knowledge of C4I and LEAN methodologies.
- Excellent verbal and written communications skills.
- Strong problem-solving skills.
- Strong Mechanical Aptitude. Education and Experience
- Bachelor of Engineering or Science Degree in Engineering or
Technology related discipline.
- Minimum 3-5 years working in a cGMP environment.
- Preferred candidate will have extensive aseptic filling
- Ability to manage teams to execute on the floor activities such
as FAT, SAT, IQ/OQ and Engineering batches Experience in data
driven approach to root cause analysis and prioritization of
continuous improvement initiatives e.g., Six Sigma
- Ability to adapt to changing priorities as project demands
- CQV experience and experience with facility start up
- Ability to explain complex technical issues to external
- Demonstrated excellence in planning and organizational skills.
Salary DOE. Excellent Benefits
Keywords: Civica Rx, Richmond , Aseptic Filling Process Engineer, Engineering , Petersburg, Virginia
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