Process Improvement Engineer

1 week ago

Carlsbad, United States Cogent Infotech Corporation Full time
Job Overview

Shift/Schedule: Monday to Friday, 8 AM to 5 PM
Position: Process Improvement Engineer
This role encompasses a 40-hour work week, primarily during the first shift, with some flexibility in start times after training.

  • Our mission is to empower our clients to create a healthier, cleaner, and safer world.
  • We support our clients in accelerating life sciences research, tackling complex analytical challenges, enhancing patient diagnostics and therapies, and boosting productivity in their laboratories.

What Impact Will You Make?

  • The Process Improvement Engineer plays a vital role in upholding our Quality Management System and spearheading enhancements through various projects.
  • This individual will be responsible for resolving daily quality challenges and leading improvement initiatives.

Key Responsibilities:

  • The ideal candidate will exhibit exceptional organizational and communication skills, along with demonstrable project management and process enhancement experience.
  • The Process Improvement Engineer will oversee daily quality concerns within manufacturing and facilitate process enhancements that may necessitate capital investment.

Main Duties Include:

  • Enhancing existing products and processes to boost efficiency and product quality within manufacturing and quality control workflows.
  • Designing, developing, and proposing engineering solutions to address capacity, cost, and quality challenges.
  • Establishing and documenting specifications by applying industry standards and best practices to fulfill product, process, and customer requirements, thereby improving overall manufacturing performance.
  • Leading Practical Process Improvements (PPI) with cross-functional teams by utilizing lean methodologies, including data analysis and statistical techniques, to enhance process efficiency.
  • Preparing and presenting reports and data analyses to colleagues, supervisors, and other internal stakeholders.
  • Updating manufacturing documentation (e.g., WINs, SOPs, and batch records) to resolve production issues, enhance quality, and implement best practices.
  • Coordinating validation activities for instruments and equipment utilized by manufacturing and quality control teams.
  • Promoting safety enhancements to ensure a secure working environment.
  • Creating and reviewing project proposals and plans with partners and stakeholders.
  • Managing project costs, documentation, and timelines to guarantee timely completion of key deliverables.
  • Effectively communicating obstacles or issues and securing necessary support for resolutions.
  • Working within our Quality Management System to conduct investigations and identify solutions related to process failures and deviations.
  • Participating in internal and external audits and addressing audit findings.
  • Identifying and implementing suitable corrective and preventative measures.
  • Collaborating with internal and external vendors for scheduling preventative maintenance and repairs of equipment.

Qualifications:

  • Bachelor's degree in a relevant field such as sciences or engineering (preferred disciplines include Mechanical, Electrical, Biomedical, or Industrial Engineering).
  • A minimum of 2 years of experience in a manufacturing environment or a related field.
  • At least 1 year of experience in an ISO or cGMP regulated manufacturing setting.
  • Familiarity with an ERP system and a basic understanding of cost accounting and standard manufacturing financials.
  • Experience with process improvement methodologies and tools (or similar continuous improvement and lean systems, such as Kaizen, Root Cause Counter Measure, etc.).
  • Proven experience collaborating with cross-functional teams on projects of varying complexity.
  • Knowledge of manufacturing processes and inter-departmental responsibilities.

Skills:

  • Proficient in Microsoft Office Suite, particularly Excel, Word, and PowerPoint.
  • Familiar with statistical methods (e.g., ANOVA, t-test, normality) and statistical software (e.g., JMP, Minitab).
  • Strong collaborative abilities and the capacity to influence others without formal authority.
  • Excellent verbal and written communication skills.
  • Ability to thrive in a fast-paced environment.
  • Consistent, diligent, and precise in executing responsibilities.
  • Positive attitude towards work and colleagues.
  • Results-oriented and data-driven approach.
  • Understanding of manufacturing operational flow, including but not limited to formulations, filling, and assembly/packaging.
  • Strong project management capabilities.
  • Proactive mindset that anticipates needs and challenges while devising solutions.
Company Overview

At Cogent Infotech Corporation, we are committed to advancing our expertise to establish new industry benchmarks. Through the continuous enhancement of our processes and the expansion of our services to meet the evolving demands across various sectors, we deliver effective, forward-thinking, and comprehensive solutions.

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