Manufacturing Operations Specialist

hace 3 días


Ponce, Ponce, Puerto Rico Eqval A tiempo completo
Job Description:

At Eqval Consulting Group, Inc., we provide services to the manufacturing industry, catering to Medical Devices, Pharmaceuticals, Biotechnologies, and more. We collaborate with an exceptional group of professionals to deliver high-quality services to our clients.

Role Overview:

The Manufacturing Engineer will play a key role in supporting New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.

Duties and Responsibilities:
  • Generate and execute validation protocols for new or replaced equipment, or process changes.
  • Perform initial set-up, conduct troubleshooting, and continuous improvement of production equipment and processes.
  • Support investigations and teams with Manufacturing and QA personnel for review and disposition of investigations on time.
Requirements:
  1. Bachelor Degree in an Engineering Field.
  2. 3+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment.
  3. 3+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation).
  4. 3+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e., Minitab).
Preferred Skills:
  • Knowledge and skills in diverse areas such as Investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma Tools.
  • Knowledge with pFMEA (analysis and development).
  • Highly Motivated, Self-Starter, and Multi-Task Oriented.
Estimated Salary:

$90,000 - $110,000 per year



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