Lead Invetigator

mîrus Consulting Group

  • Manatí, PR
  • Permanente
  • Tiempo completo
  • Hace 2 días
mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.Position Summary:The Manufacturing Scientist provides operational, scientific expertise and compliance support to Sterile and Non-Sterile Manufacturing Operations. This role is responsible for executing manufacturing investigations (QE’s), Corrective and Preventive Actions (CAPA’s), NTR’s, NOE’s, procedure development and revision, and process validation documentation. The incumbent must comply with Security guidelines, Environmental Health & Safety regulations, and current Good Manufacturing Practices (cGMP).Responsibilities:
  • Ensure timely completion/closure of QE’s, NTR’s, NOE’s, and CAPA’s within established timeframes, using appropriate tools to prevent reoccurrence.
  • Review and provide input to regulatory submissions related to manufacturing processes.
  • Lead trend evaluation for QE’s and CAPA’s.
  • Participate in new product introduction to define requirements for documentation, materials, training, and equipment modifications.
  • Support establishment of process monitoring parameters and control limits.
  • Assess deviations and process monitoring data, identifying areas for improvement.
  • Monitor and evaluate parameters in ongoing processes to optimize productivity, yields, equipment performance, and process times.
  • Provide technical assistance to recommend and implement process/equipment modifications and cost reduction initiatives, ensuring cGMP compliance.
  • Write, evaluate, and revise manufacturing documentation (SOPs, MBRs, etc.) and support training activities.
  • Assist in generation and execution of validation protocols and reports.
  • Support regulatory inspections as required.
  • Collaborate with managers and supervisors in resolving technical production issues (process/equipment troubleshooting, yield, cycle time, quality, and productivity).
  • Recommend and implement process improvements and equipment optimization strategies.
  • Participate in Environmental Regulatory and Compliance Permits as well as Process Safety Hazards evaluations.
  • Promote and model BMS Core Behaviors, fostering teamwork and collaboration.
  • Support site initiatives and execute additional assignments aligned with business needs.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

mîrus Consulting Group