Principal Process Engineer

19901 Nordhoff St, Northridge, CA 91324, USA

Principal Process Engineer for Kindeva Drug Delivery LP.

19901 Nordhoff St., Northridge, California 91324.

• 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 uptime and efficiency.
• Perform Design of Experiments (DOE) and Statistical Process Control (SPC) using Minitab to improve processes.
• Implement process improvement using Lean manufacturing tools such as Kaizen, Value Stream Mapping (VSM), Single Minute Exchange of Die (SMED), FMEA, TPM, and Poka‑yoke.
• Ensure compliance with 21 CFR Part 820 and 21 CFR Part 11 regulations.
• Conduct root cause analysis (RCA) investigations on quality deviations and execute corrective actions (CAPA) on time.
• Develop and define User Requirements Specification (URS) for new process equipment.
• Collaborate with the product development team to define commercial manufacturing processes for new products and author the necessary equipment user requirements documents.
• Evaluate OEM designs to select equipment vendors and ensure fully meeting user and FDA regulatory requirements.
• Execute design reviews and author Design Qualification Reviews for new equipment.
• Define 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 and peel tests.
• Execute equipment commissioning and qualification to ensure that equipment is installed, operating as intended, and producing products with desired quality.
• Troubleshoot processes and equipment and implement corrective actions for failures during commissioning/qualification.
• Provide training to production, maintenance, and engineering staff on 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, Solid Works, Pro‑E, Windchill.
• Travel required:
  
  10% domestic or international, visiting vendor sites for procurement and testing of new equipment.

• Bachelor’s degree or foreign equivalent in Mechanical, Systems, Electrical, Chemical, Biomedical, Manufacturing, Production Engineering, or a related field.
• Post‑bachelor progressive experience in Manufacturing Engineering, Validation Engineering, Process Engineering, Mechanical Engineering, Electrical Engineering, or a related occupation within the pharmaceutical or medical device industry.
• Seven years of experience in: ability to conduct DOE, SPC, proficiency in Minitab or other statistical software.
• Use of Minitab and similar tools.
• Designing control according to 21 CFR 820 or ISO 13485, data integrity per 21 CFR Part 11, change order, CAPA.
• Performing process development for new equipment and automated assembly lines.
• Five years of experience in: leading planning, installation, commissioning, and qualification of new manufacturing equipment (IQ/OQ/PQ).
• Using CAPA (RCA, FMEA) closure or Quality Investigation Report.
• Using Solid Works.
• Four years of experience in quality system regulations or employer‑accepted certification in quality system regulations (e.g., AAMI/ISO/ASQ or similar).

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.