Search the 20 jobs at CAI

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.

Seeking CSV Lead with 7+ years of experience in the Pharmaceutical/Life Sciences industry to oversee and execute Computer System Validation processes ensuring compliance with regulatory standards and company policies. Must have a bachelor's degree in Engineering, Chemistry, or Life Sciences.

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.

Junior CSV Engineers with 1-3 years of experience and at least 1 year of experience in the GMP field. Hiring for a permanent position; preferably located in the province of Milan.

The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, and consult on resolution plans for gaps. They will also be responsible for writing GxP computer validation and 21 CFR Part 11 related documentation.

The CQV Engineer develops documentation to support Commissioning, Qualifications, and Validation. Responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

Looking for a Senior CQV Project Manager with experience in CQV strategy, development, and field execution. Must have experience managing projects of $1m or more and leading teams of at least 6-8 engineers and consultants. Responsible for scope, schedule, and budget for projects. Preferred experience in facilities, clean utilities, biotech equipment, single use disposable, or aseptic fill finish manufacturing. PMP certification is a plus. Must have excellent problem-solving skills and proficient in various Project Management software tools.

The CQV Engineer develops documentation to support Commissioning, Qualifications, and Validation. They are responsible for protocol writing and execution, field verification, and development of summary reports at client sites.

The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. Responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

Seeking a Project Manager to join our growing operations in Switzerland. The role involves providing cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients. The Project Manager will be responsible for managing mid-sized to large projects related to process equipment and clean utilities, leading design reviews and installations, as well as coordinating and tracking progress of C&Q activities.

Seeking Project (CQV) Engineers to join our growing operations in the UK. The role involves performing commissioning, qualification, validation team activities with a direct regard for safety, generating C&Q procedures for projects, reviewing/qualifying equipment design, writing and revising qualification/verification related documents, facilitating scoping/planning of commissioning spares and consumables, tracking progress of C&Q activities, preparing qualification summary reports, executing design reviews and various activities, coordinating with project contractors and equipment vendors, allocating project resources, and coordinating support during C&Q execution.

The CQV Engineer is responsible for performing commissioning, qualification, and validation activities with a focus on safety. They will generate C&Q procedures, review and qualify lab equipment, and write/revise qualification-related documents. The engineer will coordinate with project contractors and vendors, track progress, and allocate resources for efficient execution. They should have a BS or MS in a relevant field, 5+ years of experience in CQV roles for life sciences, and excellent communication and problem-solving skills.

CAI is seeking a Qualified Person (QP) to join their growing operations in Ireland. The QP will be responsible for certifying medicinal products and providing quality and compliance guidance.

CAI is looking for a Senior CQV Engineer to join their team in Japan. The engineer will be responsible for commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. They will also be involved in protocol writing, execution, field verification, and development of summary reports at client sites.

CAI is looking for individuals with experience in commissioning, qualification, and validation to join their team in Australia.

Our project managers are technical leads with experience in CQV strategy, development, and field execution. The ideal candidate will have managed projects of $1m or more and teams of 6-8 engineers and consultants.

CAI is looking for a Project Manager with experience in commissioning, qualification, and validation in the pharmaceutical, medical device, or biotechnology industries. The Project Manager will provide leadership and guidance for the integration and delivery of CQV services to life sciences clients. They will manage projects related to process equipment and clean utilities, write and review CQV documents, allocate project resources, track progress, and coordinate support during CQV execution.

Provide project oversight for deployment of SAAS platforms within a GMP environment. Manage IT projects, their cost, scope, and timelines. Collating user requirements from impacted functional groups. Managing and collating stakeholder expectations. Key interface between Cell Therapies Pty Ltd and engaged platform providers. Ownership of project schedules and generation of status reports. Presentation of project progress to the Cell Therapies Leadership team as required.

The Quality Specialist will provide knowledge and experience in Quality Systems and Operational Quality. Responsibilities include batch disposition preparation, batch record review, compliance with regulatory requirements, and continuous improvement of quality systems. The ideal candidate should have at least 5 years of experience in GMP regulated facilities and a bachelor's degree in a science or equivalent discipline.