What are the responsibilities and job description for the Specialist Manufacturing (Process engineering, continuous improvement) position at Infotree Global Solutions?
Fully Onsite
Standard Hours
Ideal Candidate: B.S. 4 or M.S. and 2 YOE. Process engineer experience, continuous improvement ownership.
This vital role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, manufacturing process/procedures, risk assessments, process validation, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Responsibilities may include, but are not limited to:
Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.
Support process monitoring parameters and control limits based off KPIs and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports.
As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities.
Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Execute risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.
Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Ensure that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Basic Qualifications
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
Quality & Compliance Knowledge (GMP, CAPA, documentation control, risk assessments)
Technical Expertise in Manufacturing Processes
Process Improvement & Continuous Improvement
Day to Day Responsibilities:
This vital role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, manufacturing process/procedures, risk assessments, process validation, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Responsibilities may include, but are not limited to:
Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.
Support process monitoring parameters and control limits based off KPIs and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports.
As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities.
Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Execute risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.
Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Ensure that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.