Description:

We are seeking skilled and dedicated Scientists and Engineers to provide consulting services to the life sciences industry (Pharma, Biotech & Medical Devices) in OpEx, Reliability, Validation, Commissioning/Qualification and Automation projects.

Candidates must possess knowledge and experience in at least two 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. Own Change Control and ensure 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. Effective communication and project management skills.