Packaging Engineer II (964)

Civica Rx•Petersburg, VA

4d•Onsite

About The Position

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.

Requirements

5+ years of experience within the discipline is required.
B.S. in Engineering or Science discipline required.
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.
Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.
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.
Ability to explain complex technical issues to external customers/agencies.
Demonstrated excellence in planning and organizational skills.

Nice To Haves

Exposure to pharmaceutical manufacturing and operations including pen assembly, packaging equipment, and line-level serialization systems preferred.
Familiarity with engineering and architectural/construction drawings is highly advantageous.
Passion for Civica's mission to provide affordable quality generic medicines that are accessible to all.
Experience working in a cGMP environment preferred.
CQV experience and greenfield facility start-up experience preferred.

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.