Job Title: CQV Engineer

Job Description

Join a collaborative team providing Commissioning, Qualification, and Validation (CQV) support to manufacture GMP products. The role involves executing CQV protocols using Good Documentation Practices (GDP), investigating and resolving protocol exceptions or anomalies, developing technical reports, and CQV summary reports. Additionally, you will support product and process development for technology transfer by executing Designs of Experiment (DOE) and developing process ranges.

ResponsibilitiesExecute CQV protocols using Good Documentation Practices (GDP).Investigate and resolve protocol exceptions or anomalies.Develop technical reports and CQV summary reports.Develop and execute Scientific and Engineering studies to support product and process development for technology transfer.Create and revise lifecycle documents, including Design Specifications Documents, Functional Specification Documents, and Software Specifications Documents.Read and verify facility and equipment drawings, such as P&IDs and PFDs.Generate and execute Installation and Operational Qualification of new hardware, equipment, instruments, and software.Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documents.Essential SkillsMinimum 5 years of experience with Good Documentation Practices in a GMP environment.Experience in writing technical reports, developing and executing protocols, and creating summary reports.Experience in developing and executing engineering studies, supporting process development for technology transfer, and executing Designs of Experiment (DOE).Proficient with Microsoft Office (Word, Excel, PowerPoint, Project).Knowledge of US FDA (21 CFR 210, 211, 810) and EMEA regulations.Knowledgeable of Quality Management Systems, such as Change Control, CAPA, and Deviation.Knowledgeable of Validation and Commissioning/Qualification requirements.Knowledgeable of Technology Transfer, Process Development activities, and Designs of Experiment (DOE).Advanced technical writing skills with a strong understanding of formatting and document presentation.Additional Skills & QualificationsExperience with Minitab is a bonus.Experience in cleaning validation is a bonus and could lead to retention beyond 2025.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.