CAI
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As a Reliability Field Engineer, you'll gather and validate equipment specifications, manage maintenance data, draft FMEA sheets, and ensure accurate data delivery to clients. The role involves collaborating with manufacturers and performing quality control in a hands-on environment.
The Qualified Person (QP) certifies medicinal products, ensures compliance with regulatory requirements, provides quality guidance for projects, oversees quality management systems, and supports audits and investigations. They also maintain knowledge of pharmaceutical legislation and assist in continuous improvement initiatives.
The CQV Engineer oversees the development of documentation for Commissioning, Qualifications, and Validation of pharmaceutical facilities. Responsibilities include protocol writing, field verification, report generation, and managing the documentation lifecycle. The role requires expertise in GMP and life sciences, problem-solving skills, and the ability to work independently while leading project teams.
The Senior CSV Engineer is responsible for validating and qualifying computer systems, managing change controls, and ensuring compliance with regulatory requirements. This role involves preparing validation documentation, troubleshooting issues, and communicating within and outside the organization regarding validation policies. The engineer will participate in audits and manage projects using tools like Microsoft Project.
The CQV Engineer develops and manages documentation for commissioning, qualification, and validation of pharmaceutical facilities. Responsibilities include protocol writing, execution, field verification, and generating summary reports, while ensuring compliance in FDA regulated environments.
The Project (CQV) Engineer role involves conducting Commissioning, Qualification, and Validation activities in the life sciences sector, focusing on safety and project timelines. Responsibilities include generating C&Q procedures, writing and reviewing qualification documents, coordinating project resources, and conducting design reviews and equipment testing.
The Project Manager at CAI will lead cGMP integration and delivery of CQV services for Life Sciences clients, managing mid to large projects related to clean utilities and process equipment. Responsibilities include writing and approving CQV documents, managing projects, tracking progress, and coordinating activities during execution.
The Sterility Assurance Expert will lead Sterility Assurance assessments in the regulated manufacturing industry, focusing on environmental qualification, contamination control, microbiological and biological methods, and the qualification of sterilizing equipment. This role involves writing protocols and reports, participating in cross-functional projects, and managing multiple projects simultaneously while ensuring regulatory compliance and quality laboratory practices.
The Accounts Payable & Receivable Administrator will support AP & AR functions within a Shared Services setting, processing invoices, managing expense reports, adhering to policies, resolving discrepancies, and participating in improvements. Strong detail orientation and communication skills required, with a focus on accurate and timely processing.
The Salesforce Data Integrity Specialist ensures data accuracy and consistency within the Salesforce platform, implements data quality standards, conducts audits, manages user permissions, provides training, and improves data management processes. They collaborate with teams to streamline operations and enhance data accuracy.
The Process Engineer will design and specify cGMP process equipment, manage small-to-medium scale projects, participate in design reviews, and support QA Validation. Responsibilities also include revising diagrams, investigating control system issues, implementing process improvements, and ensuring compliance with relevant laws.
The Proposal Coordinator will work within a collaborative team to develop, manage, and produce proposals for the pharma/biotech industry. Responsibilities include writing proposal sections, managing compliance matrices, coordinating marketing support, conducting market research, and ensuring timely proposal delivery.
As an Inside Sales Specialist at CAI, you'll drive revenue growth in the life sciences by identifying and closing new business opportunities, collaborating with sales and marketing teams, and managing the sales process from lead generation to closing. Responsibilities include cold calling, utilizing Salesforce, managing sales activities, and developing a deep understanding of products and services to communicate value to customers.
The Quality Specialist at CAI will ensure compliance with quality systems and regulatory requirements, perform batch record reviews, and facilitate adherence to GMP standards. This role involves improving quality systems, supporting commercial manufacturing quality, and collaborating with clients to solve complex problems.
We are looking for a Junior CSV Engineer with 1-3 years of experience, ideally with at least one year of experience in GMP (Good Manufacturing Practices).
As a CQV Engineer, you will develop documentation for Commissioning, Qualification, and Validation in pharmaceutical environments, manage protocol writing and execution, and perform field verifications. You'll also provide cGMP guidance for CQV services integration and manage the documentation lifecycle. Strong technical problem-solving skills are essential for troubleshooting and project management.
The Senior CQV Engineer at CAI is responsible for developing documentation related to commissioning, qualification, and validation of pharmaceutical facilities. This role includes protocol writing and execution, field verification, and overseeing small teams for project coordination at client sites. The Engineer will ensure compliance with FDA regulations and provide leadership in cGMP practices while actively participating in troubleshooting and problem-solving.
The CSV Engineer will develop and execute validation protocols/documents, manage change controls, participate in audits, troubleshoot issues, assess compliance of systems, and coordinate with departments or contractors to maintain regulatory adherence in computer validation processes.
The Program Manager leads the Digital Enablement program, acting as a liaison between Professional Services and development teams. Responsibilities include managing communication strategies, overseeing project lifecycles, advocating for digital initiatives, and establishing performance metrics for program success.
The CQV Senior Project Manager leads the execution of CQV projects for life sciences clients, ensuring operational readiness. Responsibilities include managing project lifecycle, risk analysis, stakeholder engagement, and communicating budget impacts due to scope changes.