Mantell Associates
Mantell Associates are currently partnered with an innovative Engineering company who are searching for a Process Engineer (Visual Inspection). As Process Engineer, you will function as an integral part of the creation of packaging operations at client’s first manufacturing facility.
Process Engineer – Responsibilities:
- Management of equipment vendors including the execution of FAT & SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments
- Support execution of the Commissioning & Qualification activities for responsible equipment including FAT, SAT, commissioning, IQ, OQ, and PQ
- Responsible for drafting and executing engineering trials, DOEs, and preparation of required cGMP documentation for production operations
- Draft risk assessments and specifications for defect kits to be utilized for equipment qualification
- Coordinate technical deliverables across all 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 tools such as DMAIC and FMEA
- Manage changes for responsible equipment as per site change control procedures
- Participate in regulatory inspections (e.g. FDA, DEA audits)
- Lead improvement of equipment reliability through CI and TPM processes to support the transition from project level to sustainable manufacturing/ramp up production
Process Engineer – Requirements:
- 5 years Process Engineering experience are required, 7 years preferred
- 3 years 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 approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram)
- 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/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’s mission to provide affordable quality generic medicines that are accessible to all
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.