Process Development Scientist (Investigations/C&Q)

Ultimate Solutions

  • Juncos, PR
  • Permanente
  • Tiempo completo
  • Hace 1 mes
Description
Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Education
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Requirements
  • Available for Non-Standard Shift
  • Knowledge in Development of User Requirements Specifications of equipment
  • Knowledge in Commissioning and qualification of new and existing assets
  • KNowledge in Characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans
  • Provide support in investigations and the proposal and implementation of corrective actions related to investigations
  • Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
  • Lean six sigma, operational excellence and continues improvement in assigned projects.
  • Develop business cases for new or modifications to existing systems, to determine feasibility based on business needs, including but not limited to demand, capacity, logistics, space, financial impact and head count
  • Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components
Ultimate Solutions Corp is an equal opportunity employer.

CATSONE

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