Search the 39 jobs at FITS LLC

The Quality Specialist will review and approve validation protocols, support quality improvement initiatives, collaborate with cross-functional teams, and ensure compliance with regulatory standards while identifying and resolving process defects in the Manufacturing area.

The Assistant Project Manager will support project management activities in the Business Operations area, including coordinating project activities, maintaining documentation, developing presentations, and managing project financials. The role involves assisting the Project Manager through all project phases and ensuring effective communication with stakeholders.

The Technical Writer will create clear and accurate documentation for product development in the Pharmaceutical and Medical Devices industries, ensuring compliance with regulations and collaborating with cross-functional teams to reflect necessary data and changes. Responsibilities include developing SOPs, maintaining documents, and contributing to validation processes.

The role involves writing, executing, and maintaining Computer System Validation protocols, ensuring compliance with FDA requirements, and integrating protocols into manufacturing processes. The position requires thorough documentation of investigations and effective communication of findings to minimize recurrence of issues associated with validation.

The Engineer will provide solutions to technical problems in manufacturing operations, focusing on the Medical Devices or Pharmaceutical industry. Responsibilities include evaluating engineering techniques, troubleshooting equipment, auditing operational performance, and collaborating with various departments to complete projects efficiently.

As a CSV Specialist, you will write, execute, and maintain Computer System Validation protocols while ensuring compliance with FDA requirements and integrating these protocols into manufacturing processes. You will also handle documentation, investigations, and communication regarding validation activities to minimize recurrence of issues.

As a Senior Engineer, you will lead scientific projects, develop novel experimental strategies, and guide the resolution of technical issues while working in a lab setting. You will work independently and integrate cross-functional activities to achieve departmental objectives and milestones.

The Associate Engineer will provide quality support in manufacturing operations, leading engineering tasks, and improving quality processes. This role involves interaction with peers for project oversight and recommendations for resolution of issues. Responsibilities include tracking quality improvements, initiating change requests, and ensuring procedural readiness.

As a Project Engineer, you will develop and maintain project plans, schedules, and budgets; monitor progress, manage risks, and coordinate with stakeholders. You will handle change control, create User Requirement Specifications, assess existing infrastructure, and prepare project reports.

As a Quality Engineer, you will review and approve changes in procedures, support quality improvement initiatives, conduct investigations for nonconforming materials, and generate testing protocols while ensuring compliance within the Pharmaceutical or Medical Devices industry.

As a Technical Lead, you will oversee project scopes, design specifications, and engineering criteria, coordinate with external teams, review engineering documentation, and ensure compliance with regulations. You will also manage project schedules, facilitate vendor coordination, and implement quality assurance measures to mitigate risks and optimize project delivery.

The role involves supporting Project Managers with tracking project scope, schedule, cost, and resources, preparing funding documents, managing project accounts, and assessing project progress through reporting. Candidates will work cross-functionally to resolve vendor issues and audit capital project invoices.

The Project Engineer will oversee Capital Projects, ensuring EHS by Design review processes are completed, supporting planning, coordinating construction activities, facilitating risk assessments, and managing documentation and changes throughout the project lifecycle.

As a Quality Engineer I, you will maintain quality standards for processing materials, collaborate with engineering to ensure compliance, and conduct inspections and quality assurance tests. You'll also analyze production processes for precision and accuracy, ensuring all documentation meets compliance standards and implementing corrective measures.

The Manager of Compliance will oversee investigations for customer and external complaints, support regulatory inspections, conduct internal and external audits, and ensure compliance with GMP and regulations in laboratory and operational areas. The role includes managing document control and providing guidance on new products and processes.

The Quality Engineer will implement quality engineering processes, support validation and certification of products and methods, generate test protocols, and collaborate with cross-functional teams to deliver projects while maintaining quality standards.

As a Senior Project Manager, you'll manage project development programs, oversee budgets and rolling schedules, mitigate risks, and establish communication strategies with team members and stakeholders. You'll also participate in executive meetings and coordinate necessary actions for project functionality, ensuring effective relationships with various organizations.

The Project Engineer for Capital Projects will support the execution and coordination of various capital projects, including construction and equipment installation. Responsibilities include managing project planning and implementation, tracking budgets, ensuring regulatory compliance, and providing updates to management.

The Civil Engineer will oversee and manage site preparation tasks, collaborate with multidisciplinary teams, and ensure compliance with construction standards. Responsibilities include developing civil engineering designs, conducting site inspections, managing material testing, and maintaining project documentation, all while ensuring safety, quality, and environmental compliance.

The Architect Project Engineer will provide technical interpretation of design documents, execute projects according to quality standards, and manage communication and coordination among all parties. Responsibilities include preparing project reports, reviewing drawings for inconsistencies, coordinating system completion, and interacting with various disciplines to resolve issues.