Process Validation Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description:
Process Validation Engineer with 5+ years of engineering experience. This role includes an in-depth training program, where the consultant will be paired with a team member to review training materials and receive hands-on floor training related to process validation and supplier quality activities. The engineer will work cross-functionally to assess manufacturing and supplier quality processes, identify improvement opportunities, and implement effective solutions. Strong collaboration skills are essential, as the role requires partnering with R&D and the supplier engineering teams—experience with design for manufacturability is highly preferred to effectively communicate and resolve design-related issues. While catheter experience is not required, it is considered a strong plus.
Responsibilities:

• The ideal candidate will have a strong problem-solving mindset, able to take initiative and follow through on corrective actions. Familiarity with regulated environments and a solid understanding of validation protocols will be beneficial for success in this role.
• Process Validation, Supplier Quality, Manufacturing, Risk Management, Catheter or Capital Equipment experience.
• Design for Manufacturability, PFMEA, DFMEA, Electrical Engineering or Mechanical Engineering Background.
• Bachelor's in engineering.

All your information will be kept confidential according to EEO guidelines.