POSITION SUMMARY
The Packaging Process Engineer II will function as an integral part in the creation of pen assembly and packaging operations at Civica's first fill-finish manufacturing facility dedicated to the manufacture and supply of essential generic sterile injectable medications in Petersburg, Virginia.
Key duties include coordinating equipment vendor activities through design, fabrication, installation, qualification and serving as front-line technical support to Manufacturing. Responsible for pen assembly, packaging equipment, and line-level serialization systems. The successful candidate will routinely interface with Manufacturing, Quality, Supply Chain, and other internal functions as well as outside suppliers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Management of equipment vendors including the execution of FAT & SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments. · Complete FAT, SAT, Commissioning and Engineering Studies. · Support Validation activities such as IQ, OQ, and PQ. · Prepare the required cGMP documentation to support production operations. · 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. · Ability to quickly adapt and adjust priorities in response to unforeseen disruptions in operations. · 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.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
· Exposure to pharmaceutical manufacturing and operations including pen assembly, packaging equipment, and line-level serialization systems preferred. · Strong interpersonal and communication skills, both written and verbal. · Ability to quickly adapt and adjust priorities. · 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 Civica's mission to provide affordable quality generic medicines that are accessible to all.
EDUCATION AND EXPERIENCE
· 5+ years of experience within the discipline is required. · 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 a 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.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.