ESSENTIAL JOB FUNCTIONS
- Process Optimization:
- Collaborate with cross-functional teams to develop and implement production strategies that align with quality, cost, innovation, and customer service objectives.
- Identify opportunities for process improvements and implement solutions to enhance efficiency, reduce waste, and minimize downtime.
- Contribute to and, when applicable, lead projects and capital investment initiatives by providing technical expertise, managing vendor performance, and assisting in project execution.
- Technical Support and Troubleshooting:
- Provide engineering support to production, including floor support, non-conforming product investigations, CAPA, risk assessments, process changes, equipment qualifications and validations.
- Provide technical assistance to production personnel in resolving equipment malfunctions, process deviations, and other operational challenges.
- Lead and/or support root cause analysis investigations to identify underlying issues impacting production performance.
- Implement corrective and preventive actions to address identified root causes and prevent recurrence of issues.
- Collaborate with cross-functional teams to implement right-first-time quality measures and drive continuous improvement in product quality.
- Create, plan, review and/or execute technical documentation in support of site operating strategies and quality management system requirements.
- Performance Monitoring and Reporting:
- Review production schedules and assess the status of ongoing manufacturing processes against the standard.
- Monitor key performance indicators (KPIs) related to production efficiency, yield, and quality, identifying trends and areas for improvement.
- Prepare regular reports and presentations to communicate production performance, highlight achievements, and propose action plans for addressing performance gaps.
- Training
- Provide training and technical guidance to production personnel on equipment operation and process optimization techniques.
- Foster a culture of continuous learning and skill development within the production team, promoting knowledge sharing and cross-training initiatives.
- Apply and share the principles of lean manufacturing to improve operational performance and regulatory compliance.
COMPETENCIES
- Technical Expertise
- Detail-oriented
- Quality and Compliance
- Safety
- Good Manufacturing Practices
- Team Collaboration
- Initiative and Innovation
- Communication and Training
- Problem-Solving of Complex Technical Issues
SUPERVISORY RESPONSIBILITY
- This role has no direct supervisory responsibility. The role may provide short-term work direction to employees in support of specific project and department requirements.
WORK ENVIRONMENT
- This job operates in a professional manufacturing environment. The role routinely uses standard manufacturing equipment such as mixers, heating and cooling vessels, pumps, scales, fill lines, conveyors, computers, phones, photocopiers, filing cabinets, and other misc. equipment. The noise level in the work environment is usually moderate. The employee is occasionally exposed to fumes and airborne particles. The employee may also be exposed to mechanical moving parts and high heat.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.
- The employee is occasionally required to sit; stoop, kneel, crouch or stand for periods of time. The employee must occasionally lift and/or move up to 25 pounds.
USUAL WORKING HOURS
Monday – Friday, 7:30 a.m. to 4:30 p.m.
Capability to work extended hours or flex schedule to cover off shift support needs, if necessary.
TRAVEL
- This position may be required to travel for educational purposes and equipment purchases, as necessary.
REQUIRED EDUCATION/EXPERIENCE
- Bachelor's degree in Engineering, or related field with relevant experience.
- Three (3) or more years of related experience is required.
- Prior experience in a regulated production environment is preferred.
- Strong understanding of engineering principles, process optimization methodologies, Good Manufacturing Practices, and related regulatory requirements.
- Proficiency in CAD software and process simulation tools is preferred.
EEO STATEMENT
PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
OTHER DUTIES
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.