Principal Process Engineer

Kindeva Drug Delivery•Los Angeles, CA

About The Position

Provide technical support to process improvement initiatives on existing and new process lines. Act as a subject matter expert in the implementation and improvement of automated solutions to improve equipment’s uptime and efficiency. Perform Design of experiment (DOE) & Statistical process control (SPC) to improve process using Minitab. Process improvement using Lean manufacturing tools, such as Kaizen, Value stream mapping (VSM), Single minute exchange die (SMED), FMEA, TPM & Poka-yoke. Expert in 21 CFR Part 820 & 21 CFR Part 11 rules. Perform root cause analysis (RCA) investigation on quality deviation and execute CAPA on time. Develop and define User Requirement specification (URS) for new process equipment. Work in conjunction with the product development team to define the commercial manufacturing processes for new products and develop/author the user requirements document for the required equipment to execute that process. Evaluate OEM designs to select equipment vendors and ensure proposed designs fully meet the stated user requirements and FDA regulatory requirements. Execute design reviews and author Design Qualification Reviews new equipment. Define and equipment commissioning and qualification requirements and draft Qualification Documents. Define testing requirements and author qualification documents to ensure user requirements and regulatory requirements are met and the equipment produces products of the desired quality. Perform IQ, OQ, PQ & PPQ on new or existing automated lines. Perform test method validation such as burst test and peel test method. Execute equipment commissioning and qualification to ensure equipment is installed and operating as intended and producing products of the desired quality. Troubleshoot process and equipment and implement corrective actions for any failure during the commissioning/qualification. Provide training to production, maintenance, and engineers on the proper operating and maintenance procedures. Author SOPs and work instructions to standardize processes. Act as the subject matter expert for newly installed equipment during the transition to commercial manufacturing. Tools: Minitab, MS Visio, SolidWorks, Pro-E, Windchill. Travel required. Frequency: 10%, Area: domestic or international, Scope: Travel to vendor sites for activities involving the procurement and testing of new equipment.

Requirements

Bachelor's degree or foreign equivalent in Mechanical, Systems, Electrical, Chemical, Biomedical, Manufacturing, Production Engineering, or related field.
Requires a post bachelor progressive experience in Manufacturing Eng., Validation Eng., Process Engrg., Mechanical Engrg., Electrical Engrg. or related occupation within the Pharmaceutical or Medical device ind.
Seven (7) year’s experience in the following: I. Ability to conduct DOE, SPC, proficient in Minitab or other statistical software. II. Use Minitab and similar tools. III. Designing control according to 21 CFR 820 or ISO 13485, Data integrity requirements per 21 CFR Part 11, Change order, Corrective Actions and Preventive Actions (CAPA). IV. Performing process development for new equipment and automated assembly line.
Five (5) year’s experience in the following: V. Leading the planning, installation, commissioning, and qualification of new manufacturing equipment (IQ/OQ/PQ) VI. Using CAPA (RCA, FMEA) closure or Quality Investigation Report. VII. Use Solidworks.
Four (4) year’s experience in the following: VIII. Quality system regulations or employer accept certification in quality system regulations (e.g., AAMI/ISO/ASQ or similar regulations)

Responsibilities

Provide technical support to process improvement initiatives on existing and new process lines.
Act as a subject matter expert in the implementation and improvement of automated solutions to improve equipment’s uptime and efficiency.
Perform Design of experiment (DOE) & Statistical process control (SPC) to improve process using Minitab.
Process improvement using Lean manufacturing tools, such as Kaizen, Value stream mapping (VSM), Single minute exchange die (SMED), FMEA, TPM & Poka-yoke.
Expert in 21 CFR Part 820 & 21 CFR Part 11 rules.
Perform root cause analysis (RCA) investigation on quality deviation and execute CAPA on time.
Develop and define User Requirement specification (URS) for new process equipment.
Work in conjunction with the product development team to define the commercial manufacturing processes for new products and develop/author the user requirements document for the required equipment to execute that process.
Evaluate OEM designs to select equipment vendors and ensure proposed designs fully meet the stated user requirements and FDA regulatory requirements.
Execute design reviews and author Design Qualification Reviews new equipment.
Define and equipment commissioning and qualification requirements and draft Qualification Documents.
Define testing requirements and author qualification documents to ensure user requirements and regulatory requirements are met and the equipment produces products of the desired quality.
Perform IQ, OQ, PQ & PPQ on new or existing automated lines.
Perform test method validation such as burst test and peel test method.
Execute equipment commissioning and qualification to ensure equipment is installed and operating as intended and producing products of the desired quality.
Troubleshoot process and equipment and implement corrective actions for any failure during the commissioning/qualification.
Provide training to production, maintenance, and engineers on the proper operating and maintenance procedures.
Author SOPs and work instructions to standardize processes.
Act as the subject matter expert for newly installed equipment during the transition to commercial manufacturing.