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Job Description
The Process Engineer II, Automated Visual Inspection, will function as an integral part of the creation of packaging operations at company’s first manufacturing facility in Petersburg, Virginia. Key duties include coordinating equipment vendor activities through design, fabrication, installation, and qualification and serving as front-line technical support to Manufacturing. Responsible for vial, cartridge, and syringe automated visual inspection machines, including de-nesting and re-nesting systems. The successful candidate will routinely interface with outside vendors, Manufacturing, Quality, Engineering, Supply Chain, and Maintenance.
Essential Duties and Responsibilities:
The essential functions include, but are not limited to the following:
- 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.
- Prepare and update Preventative Maintenance (PM) tasks relating to production equipment maintenance needs.
- Lead and participate in investigations related to the equipment.
Basic Qualifications and Capabilities:
- 6+ years of Process Engineering experience.
- 3 years of Automated Visual Inspection experience.
- B.S. in Engineering or Science discipline.
- 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.
- Ability to explain complex technical issues to external customers/agencies.
- Demonstrated excellence in planning and organizational skills.
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 is highly advantageous.
- Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.
- Passion for company’s mission is to provide affordable quality generic medicines accessible to all.
Preferred Qualifications:
- Experience working in a cGMP environment.
- 3 years of Automated Visual Inspection experience.
- CQV experience and greenfield facility start-up experience.