Insight Global is hiring a Validation Engineer for our large pharmaceutical client located in Boston, MA. The Engineer will be actively involved in Commissioning, Qualification, Validation, and Requalification activities for cell and gene therapy facilities. This individual will be responsible for executing qualification protocols and collaborating with Global Engineering, Facilities Operations, GIS, QA, and PMO throughout the project's lifecycle. Reporting directly to the Manager of Validation, the Engineer will develop and execute qualification and validation test plans and protocols. They will ensure that all validation documents align with current SOPs, global standards, and cGMP guidelines. The Engineer will coordinate with onsite personnel and vendors to schedule and execute test plans, and if required, will work with the construction and operations teams to safely and effectively schedule validation activities. They will collaborate with cross-functional departmental stakeholders, including PMO, GIS, EH&S, Global Security, design teams, EHS, and QA. Completing assigned training and maintaining full compliance will be essential, as will supporting a right-the-first-time culture for all distributed documents. The Engineer will also play a crucial role in enhancing the reputation and partnership of Global Engineering with cross-functional teams.
Pay Range: $55/hr-$65/hr (Pay Range is determined by multiple factors including years of experience, industry background, level of degree, etc.)
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-A Bachelor's degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or a related discipline, with 2-4 years of CQV experience or equivalent professional experience.
-Proven experience in developing and executing protocols within the GMP industry.
-Proficiency in using Kaye Validator and Data loggers.
-Strong understanding and application of technical principles, theories, and concepts in the field, including GMP, ISO, GAMP, and ANSI standards.
-Ability to quickly learn and effectively demonstrate technical problem-solving and troubleshooting skills.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.