Process Engineer, Medical Devices & Pharma Manufacturing

Phoenix VX; Albany (GA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical premiums

401k match

Tuition reimbursement

Job summary

Phoenix VX on site in Albany, GA seeks a Process Engineer/Manufacturing Engineer/Validation Engineer to own and drive manufacturing processes from validation through continuous improvement. You’ll tackle complex production challenges, write critical documents, and work across Engineering, Quality, and Operations to optimize performance.

Strong background in validation (IQ/OQ/PQ), process troubleshooting, and technical writing is required, with familiarity in GMP-regulated medical device

Qualifications

• 3–5+ years in Medical Device and/or Pharmaceutical manufacturing.
• Engineering, Science, Technology, or closely related technical discipline.
• Demonstrated process and/or equipment validation experience.
• Strong technical writing capabilities.
• Knowledge of U.S. FDA and/or EU MDR medical device regulations.
• Experience in GMP-regulated manufacturing.
• Proven troubleshooting, analytical and problem-solving skills.

Responsibilities

• Lead and support IQ/OQ/PQ process and equipment validation.
• Troubleshoot complex manufacturing and production issues.
• Author qualification documents, validation documentation, SOPs, and technical reports.
• Analyze process data to identify risk, inefficiencies, yield improvements, and CSP opportunities.
• Support new product launches and technology transfers.
• Optimize existing commercial manufacturing processes.
• Lead technical projects from investigation through implementation.
• Partner with Operations, Engineering, Quality, Procurement, and Operational Excellence.
• Support equipment/process qualification and continued process verification.
• Contribute to Lean, Six Sigma, and continuous improvement initiatives.

Skills

IQ/OQ/PQ validation

Troubleshooting

Technical writing

GMP compliance

FDA/EU MDR knowledge

Lean Six Sigma

Education

Engineering/Science/Technology degree

Job description

Phoenix VX on site in Albany, GA seeks a Process Engineer/Manufacturing Engineer/Validation Engineer to own and drive manufacturing processes from validation through continuous improvement. You’ll tackle complex production challenges, write critical documents, and work across Engineering, Quality, and Operations to optimize performance.

Strong background in validation (IQ/OQ/PQ), process troubleshooting, and technical writing is required, with familiarity in GMP-regulated medical device