Packaging Process Engineer II (239)

BioSpace; Petersburg (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

A healthcare nonprofit is seeking a Packaging Process Engineer II to establish packaging operations at its new facility in Petersburg, Virginia. The role involves managing equipment vendors, supporting validation activities, and preparing documentation to ensure successful production processes. Candidates should have at least 5 years of relevant experience and a degree in Engineering or Science. Strong communication and project management skills are essential for this position.

Qualifications

• Minimum 5 years of relevant experience.
• Ability to manage teams and explain complex issues.

Responsibilities

• Manage equipment vendors including FAT & SAT.
• Complete FAT, SAT, commissioning, and engineering studies.
• Support validation activities such as IQ, OQ, and PQ.
• Prepare cGMP documentation to support production.
• Coordinate technical deliverables across functions.
• Lead troubleshooting and process optimization teams.
• Adapt to operational disruptions and manage changes.
• Participate in regulatory inspections.
• Improve equipment reliability.

Skills

Experience with pharmaceutical packaging equipment

Strong communication skills

Project management experience

Knowledge of Lean/Six Sigma methodologies

Mechanical aptitude and hands-on skills

Familiarity with engineering drawings

Education

B.S. in Engineering or Science

CQv experience

Greenfield start-up experience

Job description

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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, are members. Civica supplies medicines to various government agencies and health systems across 49 states. The organization aims to make quality outpatient generic medicines affordable and available through CivicaScript, and is building a new manufacturing facility in Virginia to produce sterile injectables and biosimilar insulins.

Position Summary

The Packaging Process Engineer II will play a key role in establishing packaging operations at Civica's first fill-finish manufacturing facility in Petersburg, Virginia. Responsibilities include coordinating equipment vendor activities, supporting validation and qualification activities, preparing cGMP documentation, and collaborating across departments to ensure successful production processes.

Essential Duties and Responsibilities

1. Manage equipment vendors, including FAT & SAT, maintenance visits, and continuous improvement projects.
2. Complete FAT, SAT, commissioning, and engineering studies.
3. Support validation activities such as IQ, OQ, and PQ.
4. Prepare cGMP documentation to support production.
5. Coordinate technical deliverables across functions for process and product launches.
6. Lead troubleshooting, continuous improvement, and process optimization teams.
7. Adapt to operational disruptions and manage changes per site procedures.
8. Participate in regulatory inspections.
9. Improve equipment reliability through CI and TPM processes.

Minimum Qualifications

• Experience with pharmaceutical packaging equipment and serialization systems preferred.
• Strong communication skills.
• Project management experience.
• Knowledge of Lean/Six Sigma methodologies.
• Mechanical aptitude and hands-on skills.
• Familiarity with engineering drawings is advantageous.
• Ownership of technical challenges and passion for Civica’s mission.

Education and Experience

• Minimum 5 years of relevant experience.
• B.S. in Engineering or Science.
• CQv experience and greenfield start-up experience are preferred.
• Ability to manage teams and explain complex issues.

Physical Demands and Work Environment

Includes talking, hearing, manual dexterity, occasional lifting up to 25 pounds, and working in a low to moderate noise environment.

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Information Technology
• Industries: Internet News

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