*Position Title:* Process Engineer – Packaging & Device Assembly
*Position Type:* Full-Time
*Location:* Concord, NC
*Job Function:* Engineering – Manufacturing
*Travel:* 50-60% (Domestic)

*Position Overview:*
Our top Pharmaceutical Manufacturing client is seeking a *Process Engineer* for our *Packaging and Device Assembly* operations. This role is critical in driving batch efficiencies, mechanical improvements, and optimizing processes related to packaging and device assembly. As a Process Engineer, you will be a key contributor to improving the efficiency, quality, and reliability of our manufacturing processes while collaborating closely with cross-functional teams.

You will focus on incorporating batch and mechanical efficiencies, working alongside project teams to ensure seamless equipment integration, optimization, and continuous improvement within the packaging and device assembly processes. This is a unique opportunity to impact high-quality production lines in a fast-paced, dynamic environment.

*Key Responsibilities:*
* *Process Optimization and Efficiency*
* Lead efforts to improve batch and mechanical efficiencies within packaging and device assembly processes.
* Identify and implement process improvements to reduce cycle times, increase output, and ensure the highest quality standards.
* Collaborate with production teams to resolve issues related to equipment, process variability, and system bottlenecks.
* Drive automation and integration initiatives to enhance the reliability and scalability of processes.
* *Project Leadership & Cross-Functional Collaboration*
* Serve as the technical lead for equipment and process optimization initiatives, partnering with cross-functional teams, including Operations, Engineering, Maintenance, and Quality.
* Provide technical expertise in the installation, commissioning, and qualification of new packaging and assembly systems.
* Support commissioning and qualification (C&Q) activities, process validation, and ramp-up to full-scale production.
* Lead troubleshooting efforts and resolution of process and equipment-related issues, utilizing root cause analysis (RCA) and formal problem-solving methodologies.
* *Safety and Compliance*
* Ensure a safe working environment by adhering to and enforcing all Health, Safety, and Environmental (HSE) policies and guidelines.
* Participate in and lead safety audits, hazard assessments, and safety improvement activities.
* Promote a culture of safety by ensuring that proper personal protective equipment (PPE) is utilized and that safety standards are met or exceeded.
* *Technical Documentation and Training*
* Develop and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and training materials.
* Train operators and maintenance personnel on new equipment, processes, and best practices to ensure consistent and safe operation.
* Ensure that all processes and equipment adhere to GMP, regulatory, and corporate quality standards.
* *Continuous Improvement*
* Monitor performance metrics and KPIs to track the effectiveness of process improvements.
* Analyze data to identify trends and opportunities for further optimization.
* Lead continuous improvement initiatives by applying Lean Six Sigma, Kaizen, or other methodologies to increase process efficiency.

*Minimum Qualifications:*
* *Education:* Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline) or equivalent work experience.
* *Experience:*
* Minimum of 3 years of experience in supporting production processes, particularly in packaging and/or device assembly.
* Experience in driving process optimization, batch efficiency, and mechanical improvements in a regulated manufacturing environment.
* Previous experience working with automated systems and equipment in manufacturing or assembly processes.
* *Skills & Competencies:*
* Strong analytical and problem-solving skills, with a focus on root cause analysis and continuous improvement.
* Proficiency with process control and monitoring systems, including data analysis tools (e.g., Excel, Power BI).
* Excellent communication skills and the ability to collaborate effectively across departments and with external stakeholders.
* Strong organizational and time-management skills with the ability to prioritize tasks and meet deadlines.
* Ability to travel domestically and internationally 50-60% of the time.

*Preferred Qualifications:*
* Previous experience in the *pharmaceutical, medical device, or biotechnology industries*.
* Experience with *automated packaging and device assembly lines*, including equipment delivery and startup.
* Certification in Lean Six Sigma or other process improvement methodologies.
* Familiarity with *Good Manufacturing Practices (GMP)* and regulatory requirements related to packaging and device assembly.
* *Project management* experience in managing large-scale initiatives related to equipment optimization, installation, and process improvements.

*Additional Information:*
* This position will require regular travel (50-60%) to other sites, vendors, and suppliers to support project needs, troubleshooting, and training activities.
* Must be flexible to support after-hours, weekend, and on-call activities as needed to meet business objectives.
* This position is based at the manufacturing facility in *Concord, NC*, but may require occasional travel to other locations (Raleigh, Cincinnati, Philadelphia, & Indianapolis)

Job Types: Full-time, Contract

Pay: $70.00 - $75.00 per hour

Expected hours: 40 per week

Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Vision insurance
Schedule:
* 8 hour shift
* Monday to Friday



Application Question(s):
* How many years of experience do you have with Pharmaceuticals or Pharmaceutical Manufacturing?
* How many years of experience do you have with Batch Efficiency?

Location:
* Concord, NC 28025 (Preferred)

Ability to Commute:
* Concord, NC 28025 (Required)

Ability to Relocate:
* Concord, NC 28025: Relocate before starting work (Required)

Work Location: In person