Engineer/ Specialist

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 methodology
• Strong 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.