Manufacturing Specialist Process Engineer - New Albany OH

Military Spouse Corporate Career Network•New Albany, OH

4d•Onsite

About The Position

The Specialist, Manufacturing supports the execution of manufacturing and quality systems, including continuous improvement, technology transfer and new product introductions, process validation, manufacturing processes and procedures, risk assessments, training, and non-conformance. The role applies process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. The specialist may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for process systems. The position supports process performance assessment and troubleshooting, improvement initiatives, process monitoring, technology transfers and equipment modifications, non-conformance and corrective and preventive action work, process validation, regulatory inspections, and manufacturing change control.

Requirements

Doctorate degree; or master’s degree and 2 years of experience in engineering, manufacturing, packaging, or quality in pharmaceutical, medical device, or biotechnology companies; or bachelor’s degree and 4 years of such experience; or associate degree and 8 years of such experience; or high school diploma/GED and 10 years of such experience.

Nice To Haves

Detailed technical understanding of bioprocessing and manufacturing operations.
Ability to develop, manage, and implement process improvements.
Experience with Lean principles, including Kaizen, Six Sigma, and Operational Excellence, and knowledge of problem-solving techniques.
Experience participating in and helping lead cross-functional teams.
Ability to collaborate with staff at all organizational levels, including technical and management staff in manufacturing, process development, and quality.
Experience with change-control processes and change management.
Skill in performing GMP production operations.
Regulatory knowledge and experience with regulatory interactions.
Project management skills.
Excellent organizational, technical writing, presentation, and verbal skills.
Knowledge of data analysis and control charting.

Responsibilities

Initiate, revise, and approve manufacturing procedures as document owner to keep them aligned with current operations.
Assess process performance by observing floor operations and reviewing performance data, and provide troubleshooting support.
Evaluate, plan, and implement process improvement solutions.
Assist in creating training materials and/or provide training on scientific or technical aspects of the process.
Complete risk evaluations for new or changed processes and issue summary reports.
Develop and participate in continuous improvement initiatives for cost or cycle-time reduction, including assessing and implementing special projects.
Support process monitoring parameters and control limits based on critical metrics, and recommend improvements.
Collect process-monitoring data, support deviation assessments, and help deliver quarterly process-monitoring reports on time.
Participate in technology transfer and new product introduction activities to assess documentation, material, training, and equipment modification requirements.
Assess, prioritize, justify, and support implementation and project management of process or equipment modification projects.
Triage non-conformances within established goals; assist with investigations, corrective actions, and NC/CAPA closure within established goals.
Monitor and communicate incident trends, review equipment or system root-cause investigations, and support trend evaluations.
Assist with process validation and preparation of validation protocols and reports; support collection and analysis of validation data.
May participate in regulatory inspections.
As manufacturing change owner, assess change-control records impacting the process.