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.

Responsibilities:

• Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio.
• Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file.
• Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers.
• Strong Communicator to manage stakeholders and provide bi-weekly update to Senior Leadership management.
• Minimum of 20% travel in North America - Valid US Passport Required.
• Review and assess the OQ/PQ/IQ of suppliers and support the supplier over TMV challenges.
• Responsible for End-to-End assessment on Supplier Performance (NCRs, SQNs, SCARs, SICRs,)
• Successfully integrates across multiple product lines and businesses.
• Thorough knowledge of the business areas supported including their strategies, goals, competitive environment, functional processes, and organizational dynamics.
• Fosters excellent cross-functional communications and integrates the work of managers to achieve business objectives.
• Navigate within ambiguity and drive resolution within Quality Management System.
• Strong Communicator, experienced in Statistical analysis, and power point presentation.

Requirements:

• We require candidates have an Engineering degree.
• Minimum of 10 years of related engineering experience in a medical device or regulated industry.
• Advanced Quality Engineering and Continuous Improvement skills.
• Macro and Micro engineering.
• Strong Communicator, experienced in Statistical analysis, and power point presentation.
• Need candidates with high knowledge of both Macro and Micro engineering.
• I need someone w/ an engineering capability with preferred background in Manufacturing Engineering or/and Product Quality Engineering to drive the Process Validation and Verification at the suppliers.
• I would like to see resumes with more micro engineering than macro engineering experience as we can teach the macro portion of this role. I need candidates who have spent time in their engineering roles on the operations floor and worked on the floor in the past, someone that can solve problems when they go onsite to visit suppliers and their products. Someone with stent experience would be a plus.

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