AboutCivica

Civicais a 501(c)(4) social welfare organization established in 2018 by healthsystems and philanthropies to reduce chronic generic drug shortages and relatedhigh prices in the United States. Civica is led by an experienced team ofhealthcare and pharmaceutical industry leaders. 

Today,more than 55 health systems have joined Civica. They represent over 1,500hospitals and one-third of all U.S. hospital beds. Civica has also begun tosupply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defenseand the U.S. Strategic National Stockpile of essential medicines. 

Civicarecently announced plans to expand its mission, via a unit called CivicaScript,to into the outpatient pharmacy space and to manufacture and distributeinsulins that, once approved, will be available to people with diabetes atsignificantly lower prices than insulins currently on the market. Theavailability of Civica’s affordable insulins, beginning in 2024, will benefitpeople with diabetes who have been forced to choose between life sustainingmedicines and living expenses, particularly those uninsured or underinsured whooften pay the most out of pocket for their medications.

Civica’smission is to ensure that quality generic medications are accessible andaffordable to everyone. Since established, the #1 Policy for the Civica teamhas been “Do What Is in the Best Interest of Patients.” Civica’smanufacturing facility in Petersburg, Virginia, is the future home ofaffordable insulin and essential sterile injectable medicines. The facility iscurrently in late-stage construction and hiring for the site is well-underway.

To findout more about how Civica’s innovative model is directly impacting patientcare, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learnmore about Civica’s plans to bring affordable insulin to Americans living withdiabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

The Manufacturing Specialist II will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the cartridge line and the timely production of pharmaceuticals at the Civica Petersburg, VA site. In collaboration with stakeholders, this position will support cross-functional teams with manufacturing production execution, running equipment, new product introductions, tech transfer, equipment qualifications, change management, investigations, training, 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 provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
• Assist R&D and MSAT on new product introduction and tech transfer activities to ensure steady stream of products meet commercial demand.
• Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
• Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.
• Lead efficient GMP document and record reviews to minimize routing time.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise.
• Supports regulatory inspections as an SME for the area.
• 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.
• Develop and track KPI metrics to identify opportunities, failure points, and trending models
• Flex schedule to work outside routine day shift hours at times to accommodate activities as needed.
• Participate in FAT, SAT, and other activities with equipment vendors.

Basic Qualifications and Capabilities:

• Associate degree with 6 years demonstrated ability in a cGMP production environment.

• High School degree with 8 years of experience of cGMP production experience may be considered.
• Experience with sterile fill finish manufacturing.

• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Proficiency in Microsoft Office suite.
• Strong communication and collaboration skills, with a commitment to meeting high-quality standards.
• Must be able to complete eye exam and have the visual ability to detect defects.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Basic math skills to perform required calculations (multiplication/division),
• Good deviation and investigation writing skills.
• Ability to work autonomously and within established guidelines, procedures, and practices.

Preferred Qualifications:

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Equipment qualification experience.

• Experience in using ERP systems.