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The CQV Engineer develops documentation to support Commissioning, Qualifications, and Validation in pharmaceutical facilities. Responsibilities include protocol writing, field verification, and summary report development. Requires 4-8 years of experience in commissioning and qualification activities in FDA regulated industries. Should have experience in facilities and equipment startup, utilities, building automation, and pharmaceutical manufacturing processes.

Construct, manage, and optimize data pipelines for data ingestion, storage, and provisioning. Work closely with data architects to implement designs and uphold data standards. Utilize modern data storage tools and modeling techniques to prepare data for analytical uses. Collaborate with data scientists and business analysts to support data-driven decisions. Develop and maintain scalable data infrastructure to meet business requirements. Lead the integration of new data management technologies into existing structures.

Part-time FDA Consultant position responsible for handling FDA communications, regulatory inspections, technical issues, customer issues, and new regulations. Requires 5+ years experience in GMP regulated facilities, Quality Assurance expertise, and a Bachelor's degree in a science-related discipline.

Develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Responsible for protocol writing, execution, and development of summary reports at client sites. Additionally, planning, coordinating work, and directing small teams in document development and/or execution.

The Electrical Commissioning Engineer Lead is responsible for overseeing all electrical aspects of commissioning projects, coordinating with contractors and vendors, and ensuring the safety of all personnel involved. They serve as the technical expert for the client, providing guidance on feasibility and work procedures throughout the commissioning process.

The Mechanical Commissioning Engineer Lead performs mechanical systems testing in compliance with a project schedule. They have a working knowledge of mechanical P&IDs, electrical one-line drawings, and a general understanding of mechanical systems including HVAC systems, air distribution, refrigeration systems, chilled water systems, hot water heating systems, steam heating systems, and fire protection equipment. They lead and steer all mechanical commissioning and testing activities and act as a technical expert and advisor for the client.

Seeking a Validation Engineer with a strong understanding of cGMP regulations, CSV, and C&Q principles. Responsibilities include developing and managing validation projects, executing protocols, conducting risk assessments, and collaborating with cross-functional teams.

Seeking a Validation Engineer to support Commissioning, Qualification, and Validation processes for pharmaceutical facilities. Responsibilities include executing validation activities, developing protocols, conducting qualifications, and coordinating project resources. Requires a bachelor's degree in Engineering, Chemistry, or Life Sciences with at least 4 years of experience in the Pharmaceutical/Life Sciences industry.

Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems. Manages change controls, reviews validation documentation, troubleshoots problems, and coordinates with other departments for validation tasks. Participates in regulatory audits, assesses computer systems for compliance, and manages projects.

As a High Voltage Commissioning Engineer/Agent, responsibilities include overseeing vendor commissioning activities, reviewing design documentation, developing QA/QC checklists, and traveling to sites for evaluations and audits. Requires 5 years of experience in high voltage commissioning and proficiency in Microsoft Office Suite.

Develop documentation to support Commissioning, Qualifications, and Validation. Responsible for protocol writing and execution, field verification, and development of summary reports at client sites. Plan, coordinate work, and direct small teams. Requires BS in science or engineering, 4-12 years' experience in regulated industry, technical problem-solving skills, high attention to detail, ability to multi-task, work independently, expertise in MS Word and Excel.

Lead the electrical aspects of commissioning projects for a data center, including test schedule development, test procedures finalization, review of project submittals, and coordination of contractors/vendors for electrical system testing. Conduct safety oversight, performance testing, equipment inspection, and documentation. Provide reports, ensure adherence to specifications, and engage with customers to achieve project goals. Minimum of 10-15 years data center commissioning experience required.

Develop documentation for commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. Responsibilities include protocol writing, execution, and development of summary reports. Coordinate work, direct small teams, and troubleshoot technical issues. Requires attention to detail, multitasking skills, and independence in work.

Develop documentation to support Commissioning, Qualifications, and Validation. Responsible for protocol writing, field verification, and summary report development at client sites.

Seeking a Senior CQV Project Manager to lead and manage mid-sized to large projects related to process equipment and clean utilities for Life Sciences clients. Responsibilities include providing cGMP leadership, managing project deliverables, coordinating activities, and ensuring compliance with regulatory standards. Requires 8+ years of experience in Commissioning, Qualification, Validation, and Compliance in the Life Sciences industry.

Seeking Mechanical Commissioning Engineers with a minimum of two years' experience in Data Center Commissioning to support all mechanical aspects of commissioning projects, including design reviews, safety support, script development, vendor coordination, testing, and report development.

Support the development and execution of all mechanical aspects of commissioning projects in data centers. Responsibilities include safety support, script development, vendor coordination, testing, report development, and more. Opportunity to work with cutting-edge technologies and subject matter experts. Required to have a Bachelor's degree or equivalent experience.

Seeking a Senior Pharmaceutical Commissioning Qualification Validation Engineer in Australia to develop documentation for pharmaceutical facilities, utilities, and equipment. Responsibilities include protocol writing, execution, field verification, and report development at client sites. Requires 5-12 years of experience in commissioning/qualification in FDA regulated industries.

The Validation Engineer Senior 1 is responsible for the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. They will develop documentation, write protocols, execute field verification, and develop summary reports. Other responsibilities include planning and coordinating work, troubleshooting, and providing technical problem-solving expertise. The role requires experience in commissioning and qualification in a regulated industry, excellent attention to detail, and proficiency in Microsoft Word and Excel.

The Process Engineer will be responsible for overseeing and optimizing the manufacturing processes in the pharmaceutical industry. They will work closely with cross-functional teams to identify areas of improvement and implement process enhancements.