Process Engineer - Katalyst Healthcares & Life Sciences
Richmond, VA 23173
About the Job
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.
- 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' mission to provide affordable quality generic medicines that are accessible to all.
Source : Katalyst Healthcares & Life Sciences
