Process Engineer
4 weeks ago
Mantell Associates is partnering with an innovative Engineering company to find a Process Engineer (Visual Inspection) for their first manufacturing facility. As a Process Engineer, you will play a key role in creating packaging operations.
Key Responsibilities:
- Manage equipment vendors, including FAT & SAT, on-site maintenance visits, and spare parts criticality assessments.
- Support the execution of Commissioning & Qualification activities for responsible equipment, including FAT, SAT, commissioning, IQ, OQ, and PQ.
- Develop and execute engineering trials, DOEs, and prepare cGMP documentation for production operations.
- Draft risk assessments and specifications for defect kits to be used for equipment qualification.
- Coordinate technical deliverables across business functions to support successful processes and product launches.
- Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using DMAIC and FMEA.
- Manage changes for responsible equipment according to site change control procedures.
- Participate in regulatory inspections, such as FDA and DEA audits.
- Improve equipment reliability through CI and TPM processes to support the transition from project-level to sustainable manufacturing and ramp-up production.
Requirements:
- 5 years of Process Engineering experience are required, 7 years preferred.
- 3 years of Automated Visual Inspection experience preferred.
- B.S. in Engineering or Science discipline required.
- Experience working in a cGMP environment preferred.
- Ability to manage teams to execute activities on the manufacturing floor.
- Experience in data-driven approaches to root cause analysis and prioritization of continuous improvement initiatives, such as Six Sigma, 5-why, and fishbone diagrams.
- Ability to adapt to changing priorities as project demands and business needs change.
- CQV experience and greenfield facility start-up experience preferred.
- Ability to explain complex technical issues to external customers and agencies.
- Demonstrated excellence in planning and organizational skills.
- Exposure to pharmaceutical equipment and operations, including automated visual inspection machines, preferred.
- Strong interpersonal and communication skills, both written and verbal.
- Project management experience.
- Ability to work effectively with outside suppliers.
- Knowledge of Lean/Six Sigma methodologies.
- Strong problem-solving skills.
- Strong mechanical aptitude and hands-on approach.
- Familiarity with engineering and architectural/construction drawings highly advantageous.
- Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.
- Passion for clients' mission to provide affordable quality generic medicines accessible to all.
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