Bachelor's degree in Mechanical, Manufacturing, Chemical, Industrial, or Packaging Engineering or related field.
5+ years of experience in pharmaceutical manufacturing with a focus on packaging operations.
Experience in automated packaging equipment within a GMP environment.
Strong grasp of packaging equipment validation and manufacturing startup processes.
Knowledge of FDA cGMP, EU GMP standards, and packaging best practices.
Experience in process improvements and equipment reliability initiatives.
Excellent troubleshooting, communication, and collaboration skills.
Responsibilities
Provide technical leadership in pharmaceutical packaging operations for a large-scale expansion.
Support equipment implementation, commissioning, qualification, and process optimization.
Work closely with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering teams.
Ensure regulatory compliance and efficient production performance in packaging operations.
Support startup and commercial operations of automated packaging lines.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to lead initiatives in a large-scale pharmaceutical setting.
Hands-on experience with state-of-the-art packaging technology.
Potential for career advancement within a growing company.
Full Job Description
Responsibilities:
Seeking an experienced Packaging Process Engineer to support a large-scale pharmaceutical manufacturing expansion. This consultant will provide technical leadership for pharmaceutical packaging operations, supporting equipment implementation, commissioning, qualification, process optimization, and commercial manufacturing readiness.
Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will optimize packaging operations while ensuring equipment reliability, regulatory compliance, and efficient production performance. The successful candidate will have experience supporting automated pharmaceutical packaging lines from startup through commercial operations.
Requirements:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Chemical Engineering, Industrial Engineering, Packaging Engineering, or a related engineering discipline.
5+ years of pharmaceutical manufacturing experience, with direct experience supporting packaging operations.
Experience supporting automated packaging equipment within a GMP-regulated environment.
Strong understanding of packaging equipment validation, manufacturing startup, and process qualification.
Knowledge of FDA cGMP regulations, EU GMP requirements, and pharmaceutical packaging best practices.
Experience supporting process improvements, equipment reliability initiatives, and manufacturing optimization.
Excellent troubleshooting, technical writing, communication, and cross-functional collaboration skills.
Preferred Qualifications:
Experience with serialization, aggregation, and track-and-trace systems.
Experience supporting packaging of sterile injectable products, cartridges, syringes, or combination products.
Familiarity with MES, SAP, TrackWise, or other manufacturing execution and quality systems.
Lean Manufacturing and Six Sigma experience is preferred.
Most Important Skills Needed:
Pharmaceutical packaging process engineering experience
utomated packaging line experience
Cartoners, labelers, case packers, palletizers, and packaging equipment
Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
Packaging process optimization and continuous improvement
Manufacturing troubleshooting and root cause investigations
GMP-regulated pharmaceutical manufacturing
Cross-functional collaboration with Manufacturing, Validation, Automation, and Quality
Technical documentation, engineering studies, and protocol development
