Manufacturing Specialist

Ultimate Solutions-posted 13 days ago
Full-time • Mid Level
Puerto Rico, PR
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Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets. Description The Manufacturing/Packaging Scientist will, 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.

  • 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 generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • Support establishment of process monitoring parameters and control limits.
  • Collect process-monitoring data and support the assessment of deviations.
  • Provide support of timely execution of the process monitoring quarterly reports.
  • Ensure that all Non-conformances (NC) are triaged within the established goal.
  • Responsible for authoring investigation reports.
  • Responsible for execution of corrective actions.
  • Responsible for managing NC/CAPA closure within established goal.
  • Monitor and communicate incidents trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
  • Assist with generation of process validation protocols and reports.
  • Assist with the execution of the process validation.
  • Support collection and analysis of process validation data.
  • May participate in regulatory inspections
  • Participate in the New Product Introduction (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 Change Control (CCRB) packages impacting the process.
  • Participate on the assessment or implementation of special projects or initiatives.
  • Master’s degree and 3 years of Manufacturing Operations experience OR Bachelor’s degree and 5 years of Manufacturing Operations experience.
  • Experience: Manufacturing, Procedures Revision, Change Control, CAPA’s, Deviations, Risk assessment, Problem Solving, Project Management or Experience in New Production Introduction, Documentation Management or Process Owner Experience or Experience managing change control, CAPA, CAPA EV on Trackwise and experience on CDOCS.
  • Detailed technical understanding of bioprocessing unit operations
  • Regulatory knowledge and interactions, understanding and experience
  • Experience in CAPA/CAPA EV/Change Controls/Trackwise
  • Organizational, technical writing and presentation skills.
  • Effective verbal and written communication skills (writing and presentations)
  • Ability to participate and help lead cross-functional teams.
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Team player, self-starter, persistent, tactful, and persuasive
  • Proficient managing/editing documents in MS Word and Excel
  • Fully Bilingual (English and Spanish)
  • Basic Project Management
  • Basic knowledge of control charting
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