Packaging Engineer II

Civica Rx; Petersburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Civica Rx is seeking a Packaging Process Engineer II to lead packaging operations at its Virginia facility. The role interfaces with Manufacturing, Quality, and Supply Chain to ensure compliant, efficient packaging lines and serialization systems.

The candidate will manage vendor activities, validation, and continuous improvement initiatives, requiring strong problem-solving skills and hands-on mechanical aptitude in a CGMP setting.

Qualifications

• 5+ years of experience in packaging/engineering roles within pharma or CGMP environments.
• B.S. in Engineering or Science discipline.
• Experience with cGMP environments preferred.
• CQV experience and greenfield startup exposure preferred.

Responsibilities

• Coordinate equipment vendor activities including FAT/SAT, installation, IQ/OQ/PQ, and commissioning.
• Support validation activities such as IQ, OQ, PQ and cGMP documentation.
• Prepare and maintain regulatory and batch documentation for production operations.
• Coordinate deliverables across Manufacturing, Quality and Supply Chain to support launches.
• Lead cross-functional teams to troubleshoot, drive CI/ TPM initiatives and process improvements (DMAIC, FMEA).
• Adapt priorities quickly in response to disruptions; manage changes under site change control.
• Support regulatory inspections (FDA/DEA audits) as needed.
• Improve equipment reliability and transition projects to sustainable manufacturing.

Skills

Lean Six Sigma

DMAIC

FMEA

Problem solving

Mechanical aptitude

Communication skills

Cross-functional teamwork

cGMP knowledge

Regulatory inspections

Engineering drawings

Ownership of new technical challenges

Education

B.S. in Engineering

Tools

No specific tools listed

Job description

The Packaging Process Engineer II will function as an integral part in the creation of 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 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.
• Exposure to pharmaceutical packaging equipment and operations including packaging equipment and line-level serialization systems preferred.
• Strong interpersonal and communication skills, both written and verbal.
• Ability to quickly adapt and adjust priorities.
• 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.