Process Engineer II, Automated Visual Inspection (544)

BioSpace; Petersburg (VA); On-site; USD 70,000 - 110,000; Full time

Job summary

An innovative nonprofit organization is seeking a Process Engineer II to play a vital role in establishing packaging operations at a new manufacturing facility. This role involves managing equipment vendors, leading troubleshooting efforts, and ensuring compliance with regulatory standards. If you have a passion for improving healthcare access and possess strong engineering skills, this position offers an exciting opportunity to contribute to a mission-driven organization focused on eliminating drug shortages and providing affordable medicines. Join a dedicated team that values patient welfare over profits and make a significant impact in the healthcare industry.

Qualifications

• 6+ years of Process Engineering experience required.
• Experience with Automated Visual Inspection and continuous improvement tools.
• Strong project management and communication skills needed.

Responsibilities

• Manage equipment vendors and support commissioning activities.
• Lead troubleshooting and process optimization initiatives.
• Coordinate technical deliverables for product launches.

Skills

Process Engineering

Automated Visual Inspection

Root Cause Analysis

Continuous Improvement Tools

Project Management

Lean/Six Sigma Methodologies

Strong Communication Skills

Problem-Solving Skills

Education

B.S. in Engineering

B.S. in Science

Tools

DMAIC

FMEA

Job description

Process Engineer II, Automated Visual Inspection (544)

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About Civica

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Civica is a market-based nonprofit created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, have joined Civica. Civica supplies medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, currently serving 49 states.

Its mission has expanded to CivicaScript, providing affordable outpatient generic medicines through partnerships with trusted manufacturers, payors, and pharmacies, enabling cost savings.

The upcoming 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables in shortage, biosimilar insulins, and more, ensuring access to affordable medicines for all Americans.

The Civica Foundation supports philanthropic efforts for affordable medications, including bringing insulin to all Americans.

Civica promotes a movement prioritizing patient welfare over profits, aiming to eliminate shortages and stabilize prices.

Learn more at www.civicarx.org.

Job Description

The Process Engineer II, Automated Visual Inspection, will be integral to establishing packaging operations at Civica's first manufacturing facility in Petersburg, VA. Key duties include coordinating vendor activities from design to qualification and providing technical support to manufacturing. Responsible for vial, cartridge, and syringe automated visual inspection machines, including de-nesting systems. The role involves interfacing with vendors, manufacturing, quality, engineering, supply chain, and maintenance teams.

Essential Duties and Responsibilities

• Manage equipment vendors, including FAT & SAT, maintenance visits, and continuous improvement projects.
• Support commissioning and qualification activities, including FAT, SAT, IQ, OQ, and PQ.
• Draft and execute engineering trials, DOEs, and cGMP documentation.
• Draft risk assessments and specifications for defect kits for equipment qualification.
• Coordinate technical deliverables across functions for process and product launches.
• Lead troubleshooting, process optimization, and continuous improvement initiatives using DMAIC and FMEA tools.
• Manage changes per site change control procedures.
• Participate in regulatory inspections (FDA, DEA).
• Improve equipment reliability through CI and TPM processes to support production ramp-up.
• Prepare and update preventative maintenance tasks.
• Lead investigations related to equipment issues.

Basic Qualifications and Capabilities

• 6+ years of Process Engineering experience.
• 3+ years of Automated Visual Inspection experience.
• B.S. in Engineering or Science.
• Team management skills on the manufacturing floor.
• Experience with root cause analysis and continuous improvement tools (Six Sigma, 5-Why, fishbone).
• Ability to adapt to changing priorities.
• Strong communication skills, both written and verbal.
• Project management experience.
• Experience working with outside suppliers.
• Knowledge of Lean/Six Sigma methodologies.
• Problem-solving skills and mechanical aptitude.
• Familiarity with engineering drawings is advantageous.
• Ownership of technical challenges and projects.
• Passion for Civica's mission to provide affordable medicines.

Preferred Qualifications

• Experience in a cGMP environment.
• 3+ years of Automated Visual Inspection experience.
• CQV experience and greenfield facility start-up experience.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Internet News

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