Pharma Packaging Process Engineer II - CI & GMP Focus

Civica Rx; Petersburg (VA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Civica Rx in Petersburg, Virginia, seeks a Packaging Process Engineer II to help build pen assembly and packaging operations at our first fill-finish facility. You will coordinate vendor activities, lead commissioning, validation, and CI efforts while collaborating with Manufacturing, Quality, and Supply Chain to ensure successful product launches.

Applicants should have 5+ years in engineering, a B.S. in Engineering or Science, and experience in a cGMP environment; Six Sigma and data-driven

Qualifications

• 5+ years of experience in the discipline is required.
• B.S. in Engineering or Science discipline required.
• Experience in a cGMP environment preferred.
• Experience with data-driven root cause analysis (Six Sigma, 5-why, fishbone).
• Ability to adapt to changing priorities and manage teams on the manufacturing floor.

Responsibilities

• Coordinate equipment vendor activities including FAT/SAT, commissioning and installation.
• Support validation activities: IQ, OQ, PQ.
• Prepare cGMP documentation to support production operations.
• Lead cross-functional teams to troubleshoot and improve processes using DMAIC and FMEA.
• Participate in regulatory inspections and improve equipment reliability.

Skills

Project management

Problem solving

Communication

Supplier collaboration

Lean Six Sigma

Education

B.S. in Engineering or Science

Job description

Civica Rx in Petersburg, Virginia, seeks a Packaging Process Engineer II to help build pen assembly and packaging operations at our first fill-finish facility. You will coordinate vendor activities, lead commissioning, validation, and CI efforts while collaborating with Manufacturing, Quality, and Supply Chain to ensure successful product launches.

Applicants should have 5+ years in engineering, a B.S. in Engineering or Science, and experience in a cGMP environment; Six Sigma and data-driven