Inteldot
Engineer/ Specialist
Inteldot, Juncos, Juncos, us, 00777
We are seeking skilled and dedicated Scientists, Quality Specialist and Engineers to provide consulting services to the life sciences industry (Pharma, Biotech & Medical Devices) in OpEx, Reliability, Validation & CSV, Commissioning/Qualification and Automation projects (Packaging, Manafucaturing and/or Laboratory).
Candidates must possess knowledge and experience in two or more of the following areas:
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.Working knowledge and experience with Quality Risk Assessment (FMEA and/or QRAES).Experience with change control, nonconformance, corrective and preventative actions.Experience in troubleshooting, technical knowledge on packaging equipment, vision system experience and PLC logic and sensors basic knowledge.Knowledge and experience in facilities decommissioning process.Validation and characterization process and development of documentation that support the activities (validation/characterization).Lean Six Sigma or any other improvement methodologyStrong knowledge of the Change Control process ensuring implementation within the established goal.Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage.
Qualifications:
Bachelor’s degree in
sciences or
engineering
and five
(5) years of experience
in a similar role. Proven experience in the Pharma, Biopharma, or Medical Devices industry. Excellent project management and problem-solving skills. Ability to work collaboratively in a team environment. Fully bilingual.
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Candidates must possess knowledge and experience in two or more of the following areas:
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.Working knowledge and experience with Quality Risk Assessment (FMEA and/or QRAES).Experience with change control, nonconformance, corrective and preventative actions.Experience in troubleshooting, technical knowledge on packaging equipment, vision system experience and PLC logic and sensors basic knowledge.Knowledge and experience in facilities decommissioning process.Validation and characterization process and development of documentation that support the activities (validation/characterization).Lean Six Sigma or any other improvement methodologyStrong knowledge of the Change Control process ensuring implementation within the established goal.Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage.
Qualifications:
Bachelor’s degree in
sciences or
engineering
and five
(5) years of experience
in a similar role. Proven experience in the Pharma, Biopharma, or Medical Devices industry. Excellent project management and problem-solving skills. Ability to work collaboratively in a team environment. Fully bilingual.
#J-18808-Ljbffr