Process Engineer II _ Automated Visual Inspection (544)

Civica Rx•Petersburg, VA

About The Position

The Process Engineer II, Automated Visual Inspection, will be an integral part of developing packaging operations at Civica's manufacturing facility in Petersburg, Virginia. The role is responsible for automated visual inspection machines for vials, cartridges, and syringes, including de-nesting and re-nesting systems, and provides front-line technical support to Manufacturing. The position routinely interfaces with external vendors and teams across Manufacturing, Quality, Engineering, Supply Chain, and Maintenance. The engineer coordinates vendor activities from equipment design and fabrication through installation and qualification, supports commissioning and qualification, and prepares engineering trials and cGMP documentation. The role also leads troubleshooting, investigations, equipment reliability and continuous improvement efforts, and supports equipment changes and regulatory inspections.

Requirements

At least 6 years of Process Engineering experience.
At least 3 years of automated vision system experience.
Bachelor of Science in an Engineering or Science discipline.
Ability to manage teams executing activities on the manufacturing floor.
Experience using data-driven root-cause analysis and prioritizing continuous improvement initiatives, such as Six Sigma, 5-why, or fishbone diagrams.
Ability to adapt to changing priorities as project demands and business needs change.
Ability to explain complex technical issues to external customers or agencies.
Demonstrated excellence in planning and organizational skills.
Strong written and verbal interpersonal and communication skills.
Project management experience.
Ability to work effectively with outside suppliers.
Knowledge of Lean/Six Sigma methodologies.
Strong problem-solving skills.
Strong mechanical aptitude and a hands-on approach.
Demonstrated ability and willingness to take ownership of new technical challenges and assigned projects.
Passion for Civica's mission to provide affordable, quality generic medicines that are accessible to all.

Nice To Haves

Experience working in a cGMP environment.
Commissioning, qualification, and validation (CQV) experience.
Greenfield facility start-up experience.
Familiarity with engineering and architectural/construction drawings.

Responsibilities

Manage equipment vendors, including FAT and SAT execution, on-site maintenance visits, continuous improvement projects, and spare-parts criticality assessments.
Support commissioning and qualification activities for assigned equipment, including FAT, SAT, commissioning, IQ, OQ, and PQ.
Draft and execute engineering trials and DOEs, and prepare required cGMP documentation for production operations.
Draft risk assessments and specifications for defect kits used in 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 and drive continuous improvement and process optimization using tools such as DMAIC and FMEA.
Manage changes for assigned equipment according to site change-control procedures.
Participate in regulatory inspections, including FDA and DEA audits.
Improve equipment reliability through continuous improvement and TPM processes to support the transition from project work to sustainable manufacturing and ramp-up production.
Prepare and update preventative maintenance tasks for production equipment.
Lead and participate in equipment-related investigations.