Packaging Process Engineer II — Sterile Fill/Finish Ops

BioSpace; Petersburg (VA); On-site; USD 110,000 - 140,000; Full time

Job summary

Civica in Petersburg, Virginia, seeks a Packaging Process Engineer II to help build pen assembly and packaging operations at our first fill-finish facility for essential generic sterile injectables.

Role includes leading equipment qualification, line integration, and collaboration with Manufacturing, Quality, and suppliers. You’ll drive CI/ TPM using DMAIC and FMEA to ensure scalable, compliant production.

Qualifications

• Pharmaceutical manufacturing experience preferred, including pen assembly and serialization.
• Strong communication and interpersonal skills, both written and verbal.
• Project management experience and ability to work with outside suppliers.
• Knowledge of Lean/Six Sigma methodologies and problem solving.
• Strong mechanical aptitude and willingness to own new technical challenges.
• Familiarity with engineering drawings is advantageous.
• Ability to adapt to changing priorities in a fast-paced environment.
• Commitment to Civica's mission to provide affordable generic medicines.

Responsibilities

• Manage equipment vendors, FAT & SAT, and on-site maintenance activities.
• Complete FAT, SAT, Commissioning and Engineering Studies.
• Support IQ, OQ, and PQ validation activities.
• Prepare cGMP documentation to support production operations.
• Coordinate technical deliverables across functions for launches.
• Lead cross-functional teams to troubleshoot and drive CI/TPM.
• Adapt priorities in response to disruptions on the line.
• Manage equipment changes per site change control procedures.
• Participate in regulatory inspections (FDA/DEA).
• Improve equipment reliability to enable ramp-up manufacturing.

Skills

Project management

Lean/Six Sigma methodologies

Problem solving

Mechanical aptitude

Communication skills

Adaptability

External supplier collaboration

Quality systems awareness

Cross-functional teamwork

Documentation (cGMP)

Education

Bachelor's degree in Engineering or Science

Tools

DMAIC

FMEA

IQ/OQ/PQ validation

Job description

Civica in Petersburg, Virginia, seeks a Packaging Process Engineer II to help build pen assembly and packaging operations at our first fill-finish facility for essential generic sterile injectables.

Role includes leading equipment qualification, line integration, and collaboration with Manufacturing, Quality, and suppliers. You’ll drive CI/ TPM using DMAIC and FMEA to ensure scalable, compliant production.