Specialist Manufacturing

hace 3 semanas

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary: With minimal supervision, support the execution of manufacturing and 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 the primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Responsibilities:

  • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
  • Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
  • Provide troubleshooting support.
  • Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • Support the establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
  • Provide support for the timely execution of the process monitoring quarterly reports.
  • Ensure that all Non-conformances are triaged within the established goal.
  • Author investigation reports.
  • Execute corrective actions.
  • Manage NC/CAPA closure within the established goal.
  • Monitor and communicate incident trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
  • Assist with the generation of process validation protocols and reports.
  • Assist with the execution of the process validation.
  • Support the collection and analysis of process validation data.
  • May participate in regulatory inspections.
  • Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
  • Assist manufacturing change owner on CCRB packages impacting the process.
  • Participate in the assessment or implementation of special projects or initiatives.
  • Other functions may be assigned.

Skills:

  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in GMP production operations.
  • Regulatory knowledge and interactions.
  • Ability to participate in and help lead cross-functional teams.
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Strong organizational, technical writing, and presentation skills.
  • Basic project management skills.
  • Basic knowledge of control charting.

Requirements

Qualifications:

  • 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.
  • Project Management skills and experience.
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction in a remote environment.
  • Experience managing quality records (Deviations, CAPAs, CAPA-EV, Change Controls) using TrackWise or Veeva Systems.
  • Experience navigating in SAP (ERP) system.
  • Excellent communication skills, both written and verbal, including technical writing and presentation skills, with the ability to collaborate productively with technical and senior management staff.
  • Strong negotiation skills when working with external suppliers and internal team members.

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