FITS LLC
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The Senior Engineer will collaborate with engineering teams to optimize maintenance strategies for manufacturing equipment, develop performance metrics, support troubleshooting efforts, and apply advanced engineering techniques. The role involves supervising and coordinating engineering staff and contributing to engineering policy and procedure development.
As a Project Scheduler Consultant, you will create, monitor, and analyze project schedules, ensuring accuracy and version control. Your responsibilities include reporting project status, supporting project change management, maintaining risk registers, and developing communication strategies.
The Senior Engineer will oversee complex engineering assignments, develop engineering policies, supervise a small team, and apply advanced engineering techniques. They will lead projects, ensure adherence to engineering principles, and contribute to the development of innovative solutions in the pharmaceutical or medical device industry.
The Sr. Process Automation Engineer will provide technical support in manufacturing, implement equipment modifications for quality standards, and integrate equipment and material capabilities. Responsibilities include developing manufacturing processes, ensuring compliance with regulations, and collaborating with design teams to enhance production efficiency.
As a Sr. Design Automation Engineer, you will develop and apply CAD software engineering methods, evaluate technical projects, define specifications, and integrate machine control systems while collaborating with team members and ensuring high-quality results.
As an Automation Project Manager, you will develop and manage project schedules, track budgets, ensure resource allocation, and maintain compliance with regulatory standards in the Pharmaceutical industry. You will also manage change notifications and generate project status reports for stakeholders.
The Project Scheduler Consultant will create, monitor, and analyze project schedules, ensuring accuracy and managing project risks, while supporting the project manager and coordinating tasks and reports in the pharmaceutical and medical device industries.
Manage all aspects of pharmaceutical industry projects including planning, implementation, monitoring, completion, and follow-up. Ensure project goals are understood, maintain budgets, assess issues, and provide solutions while liaising with various functional areas and supervising project support staff.
The Project Engineer will support the execution of capital projects, manage project aspects including planning and implementation, develop solutions to project issues, track budgets, maintain schedules, and ensure compliance with regulatory requirements. The role requires coordination with various teams and providing management support through formal presentations and updates.
As an EHS Safety Specialist, you will ensure environmental compliance and effective safety practices within the organization. Daily responsibilities include maintaining workplace procedures, supervising environmental objectives, communicating with contractors, and conducting environmental risk assessments. You must promote a culture of safety and environmental responsibility and coordinate waste management systems across operations.
The Sr. Associate EHS is responsible for ensuring compliance with EH&S regulations, developing and implementing safety programs, conducting inspections, preparing reports, and training staff. The role requires evaluating safety practices and regulations, interfacing with regulatory agencies, and supervising technical support staff as needed.
The Quality Specialist is responsible for reviewing and approving validation protocols, ensuring compliance with quality standards, supporting quality improvement initiatives, and collaborating with cross-functional teams. This role involves identifying manufacturing process defects, suggesting corrective actions, and enhancing validation processes for efficiency and effectiveness.
The Accounting Assistant supports the Accounting and Human Resources departments by performing clerical and administrative tasks, preparing and reviewing documents in Word and Excel, assisting with payroll, maintaining databases, and supporting audits. The role requires organizational skills, critical thinking, and fluency in Spanish and English.
As a Quality Engineer, you will support the Regulatory Affairs team in managing EU MDR certification information, conduct risk and gap assessments, handle regulatory compliance issues, develop SOPs for manufacturing processes, and provide training to staff on compliance matters.
As a Technical Writer, you will create clear and accurate documentation for product development and technical processes, ensuring compliance with industry regulations. You will collaborate with cross-functional teams, maintain up-to-date documentation, and support validations and qualifications per SOPs.
The Engineer will focus on Computer System Validation (CSV) activities in the manufacturing area, ensuring compliance with FDA requirements. Responsibilities include writing, executing, and maintaining CSV protocols, integrating protocols into manufacturing processes, documenting investigations of product and batch failures, and ensuring thorough documentation within the quality system.
As an Engineer, you will solve technical problems, evaluate engineering techniques, audit equipment performance, and collaborate across multiple departments. You will work under supervision and assist in engineering projects involving design, construction, and cost estimation.
The CSV Specialist will be responsible for writing, executing, and maintaining Computer System Validation (CSV) protocols. This role ensures compliance with FDA requirements, timely documentation of protocols, and thorough investigations of any product or batch failures. The position requires collaboration to seamlessly integrate validation processes into manufacturing operations while maintaining high-quality standards.
As a Safety Manager, you will ensure a safe work environment by managing safety activities, ensuring OSHA compliance, conducting risk assessments, and leading safety audits. Your responsibilities include taking corrective actions, working with project teams, and maintaining safety performance metrics. You will also conduct daily site walks, lead toolbox talks, and oversee job hazard analyses.
Lead the development and oversight of project scopes, engineering specifications, and design criteria for Capital Projects in the Pharmaceutical sector. Coordinate with external contractors, perform reviews of engineering documentation, and ensure compliance with regulatory standards. Engage in value engineering and risk mitigation while maintaining project goals and timelines.