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Specialist Manufacturing

United States, Juncos · Job Posted February 20, 2026
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Job Description

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Job Responsibility

  • Initiate, revise, and approve manufacturing procedures
  • Assess process performance and implement solutions for process improvement
  • Provide troubleshooting support
  • Assist in generation of training materials
  • Support establishment of process monitoring parameters and control limits
  • Ensure that all Non-conformances are triaged within the established goal
  • Author investigation reports
  • Execute corrective actions
  • Manage NC/CAPA closure
  • Monitor and communicate incidents trends
  • Review equipment/system Root Cause Analysis investigations
  • Assist with generation and execution of process validation protocols and reports
  • May participate in regulatory inspections
  • Participate in the NPI process
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects
  • Assist manufacturing change owner on CCRB packages
  • Participate on the assessment or implementation of special projects or initiatives

Requirements

  • Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience OR Associate’s degree and 10 years of Manufacturing Operations experience OR High school diploma / GED and 12 years of Manufacturing Operations experience
  • Detailed technical understanding of bioprocessing unit operations
  • Skilled in performance of GMP production operations
  • Regulatory knowledge and interactions
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
  • Organizational, technical writing and presentation skills
  • Basic project management skills
  • Basic knowledge of control charting

Nice to have

  • Bachelor's in Science or Engineering is preferred
  • Manufacturing Experience
  • Hands on experience managing CAPA & Change Controls
  • Document revisions
  • VEEVA

What we offer

  • Medical
  • dental
  • vision care
  • backup dependent care
  • adoption assistance
  • infertility coverage
  • family building support
  • behavioral health solutions
  • paid parental leave
  • paid caregiver leave
  • training programs
  • professional development resources
  • mentorship programs
  • employee resource groups
  • volunteer activities

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