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

Responsible to generate and execute validation protocols for new or replaced equipment, or process changes. Perform initial set-up, conduct and/or support troubleshooting, including continuous improvement, of production equipment and processes. Support investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigations on time.

Minimum Requirements:

• Bachelor Degree in an Engineering Field.

• 2+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment.

• 2+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation).

• 1+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).

• Knowledge and skills (1-3 years) 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.

• Computer literate (Word, Excel, Power Point, Minitab).

• Excellent communicator (spoken, written) in both, English and Spanish.





Quality Engineer

Validation Engineer / Specialist

(PR east - Caguas, Juncos, Las Piedras PR south - Ponce PR west - Mayaguez)

The Validation Specialist must have experience with validation projects in Pharmaceutical and Medical Devices environments. 

Minimum Requirements:

• Bachelor Degree in an Engineering or Natural Sciences field

• 1-5 years of knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.
  

• 1-5 years of Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.

• 1-5 years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).
  

• Knowledge in Computer System Validation (CSV).

• Good technical writing skills in English and Spanish.

• Project management skills required.
  

• Fully bilingual (English and Spanish).



CSV Engineer

Minimum Requirements:

• Bachelor Degree in Sciences or an Engineering Field (Industrial, Mechanical, Computer Engineers preferably)

• 3+ years of knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.

• Knowledge on manufacturing automated and semi-automated equipment including its PLCs, Hardware and Software testing.

• Knowledge on facilities/utilities critical to quality equipment, including SCADA Systems and automated systems

• 3+ years of computer system validation (IQ, OQ, PQ protocols generation and execution, deviations and reports generation).

• Knowledge in Computer System Validation (CSV) based in System Development Life Cycle (SDLC) and GAMP.

• Knowledge on statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).

• Fully bilingual (English and Spanish