Process Development Associate

The Steely Group

Thousand Oaks, CA

JOB DETAILS
SKILLS
Analysis Skills, Biology, Calibration, Chemistry, Communication Skills, Continuous Improvement, Cost Control, Cross-Functional, Data Analysis, Data Processing, Documentation, Equipment Validation, Establish Priorities, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Identify Issues, Industry Standards, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Multitasking, Problem Solving Skills, Procedure Development, Procedure Implementation, Process Analysis, Process Development, Process Improvement, Process Manufacturing, Process Validation, Product Costing, Project/Program Management, R Programming Language, Regulations, Regulatory Submissions, Reporting Skills, Research & Development (R&D), Team Player, Validation Plan
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago

A leading organization is seeking a highly motivated Process Development Associate to join its dynamic team. This role offers the opportunity to work at the forefront of process innovation and optimization, contributing to the development of efficient manufacturing procedures and product quality improvements. The ideal candidate will be integral to improving process efficiency, supporting validation activities, and collaborating across departments to drive continuous improvement initiatives. This position provides valuable career growth opportunities and exposure to cutting-edge industry practices, making it an excellent step for professionals eager to expand their expertise in process development and manufacturing excellence.

Key Responsibilities:
  • Assist in the development, optimization, and scale-up of manufacturing processes for new and existing products.
  • Conduct process validation activities, including testing, documentation, and analysis to ensure compliance with industry standards.
  • Collaborate with cross-functional teams such as R&D, Quality, and Production to troubleshoot process issues and implement improved procedures.
  • Gather and analyze process data to identify inefficiencies and recommend solutions for process enhancement.
  • Prepare detailed reports and documentation for regulatory submissions, audits, and internal reviews.
  • Support equipment qualification, calibration, and maintenance activities relevant to process development.
  • Participate in ongoing process improvement projects to increase efficiency, reduce costs, and ensure product quality.

Qualifications:
  • Bachelor’s degree in Engineering, Chemistry, Biology, or related field.
  • Proven experience in process development, manufacturing, or related operations within a regulated industry.
  • Strong analytical skills with the ability to interpret data and translate it into action plans.
  • Knowledge of validation protocols, equipment qualification, and regulatory standards (e.g., FDA, ISO).
  • Excellent communication and teamwork abilities.
  • Ability to manage multiple projects and prioritize tasks effectively.

Work Location:
Onsite in Thousand Oaks, California, United States.

About the Company

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The Steely Group