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Manufacturing Equipment Specialist

2 months ago

Plano, Texas, United States Collabera Full time
Job Summary

We are seeking a highly skilled Manufacturing Equipment Specialist to join our team at Collabera. As a key member of our operations team, you will be responsible for the installation, setup, and qualification of manufacturing equipment within a regulated environment.

Key Responsibilities:
  • Equipment Installation and Validation: Execute installation, setup, and qualification of manufacturing equipment according to regulatory and company standards, with a focus on Installation Qualification (IQ) to ensure equipment is installed and functioning correctly.
  • Regulated Environment Compliance: Work within a regulated environment, ensuring adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and other relevant regulations.
  • Project Leadership and Process Improvement: Lead and support various projects related to equipment installation, process optimization, and continuous improvement initiatives.
  • Documentation and Reporting: Prepare and maintain detailed documentation and reports of equipment installation, validation processes, and any deviations, ensuring accuracy and compliance.
  • Technical Expertise: Utilize AutoCAD for equipment layout and design when needed, and apply knowledge of Manufacturing Execution Systems (MES) to support operations.
  • Collaboration: Work closely with cross-functional teams, including Engineering, Quality Assurance, and Production, to ensure seamless execution of projects and equipment setups.
Requirements:
  • Experience: Minimum of 5 years as a Technician in a manufacturing environment, preferably within the medical device or pharmaceutical industry, with experience leading projects and driving process improvements.
  • Technical Skills: Proficiency in AutoCAD is a plus, and strong knowledge of MES (Manufacturing Execution Systems) is required. Must be proficient in MS Suite, particularly Excel and Word.
  • Lean Six Sigma: Knowledge of Lean Six Sigma principles is highly preferred for driving process improvements and optimizing workflows.
  • Education: Bachelor's degree (BS) in Engineering or equivalent preferred, or recent graduates with relevant industry experience.
Additional Requirements:
  • Work Environment: Must be comfortable working in a regulated environment with strict adherence to compliance and quality standards.
  • Physical Requirements: Ability to work on a 5/8 or 4/10 shift schedule from 6:00 AM to 4:30 PM, with potential overtime as needed.