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.
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
