FITS LLC
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The role involves leading engineering projects, developing policies and procedures, supervising staff, and applying advanced engineering techniques within the pharmaceutical or medical device 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.
The Engineer will solve technical problems, evaluate and apply engineering techniques, and function as a technical expert during troubleshooting operations. Responsibilities include auditing operational performance, working with various departments, managing projects, and generating cost estimates.
The Document Control role involves managing and updating documentation tools, providing metrics on documentation progress, attending project meetings, and reviewing and approving controlled documentation. Responsibilities include communication of documentation status and workload management.
The Document Control role involves managing documentation, filing, retention, and data entry tasks within the Utility Areas. Responsibilities include maintaining logs of documents, providing originals during audits, and ensuring compliance with filing processes.
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 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.
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.
As a Safety DRI, you will develop and manage safety programs, conduct audits and inspections, provide safety training, and ensure compliance with OSHA and EPA regulations in construction sites, particularly within the pharmaceutical industry, while fostering a positive safety culture and collaborating with project teams.
As a QC and CVS Specialist, you will conduct Computerized System Validation (CSV) activities, manage change control records, ensure compliance with regulations, and collaborate with cross-functional teams to maintain accurate documentation for laboratory systems.
As an Automation Engineer, you will assist in designing and implementing automated systems, conduct testing and troubleshooting, collaborate with teams to optimize workflows, ensure compliance with regulatory standards, maintain documentation, support system maintenance, and participate in improvement initiatives.
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 Associate Engineer will provide quality support in the pharmaceutical and medical devices industry, focusing on manufacturing operations, quality improvement actions, and procedural readiness. The role involves leading complex engineering tasks, resolving issues, and collaborating with peers to ensure the highest quality standards in manufacturing processes.
As a Process Development Scientist, you'll design and conduct scientific experiments, provide input for new processes, and ensure compliance with protocols. You'll analyze data, author scientific reports, and address issues with innovative protocols while collaborating in a dynamic lab environment.
As a Project Manager for capital projects, you will oversee all stages of project management, including planning, implementation, monitoring, and completion. You'll manage timelines, assess issues, maintain project budgets, and ensure compliance with regulatory standards while collaborating with various teams and stakeholders to achieve project goals.
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.
The CAPA Specialist will manage quality investigations, CAPAs, and maintain quality assurance within utility operations. Responsibilities include collaborating with clients, sustaining quality programs, mentoring team members, providing direction to vendors, and ensuring compliance with SOPs in a pharmaceutical and medical device manufacturing environment.