6347- CQV Engineer / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

This role leads the process of Clean Room qualification and the associated validation of related equipment such as incubators, cryo freezers, and HVAV.  You will be responsible for the authorization and execution of required validation protocols, temperature mapping studies, smoke studies Validation Summary reports pertaining to the qualification of a Clean Room environment in a pharmaceutical manufacturing facility. 

• →Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• →Running test scripts and documenting results
• →Adherence with project schedule for all assigned activities
• →Maintaining clear, detailed records qualification and validation
• →Documenting impact and risk assessments as part of a team
• →Completing user interface testing, software verification, and complete alarm testing on automated systems
• →Developing, reviewing, and executing testing documentation
• →Making recommendations for design or process modification based on test results when executing test scripts
• →General understanding of capital equipment implementation and process knowledge
• →Understanding validation documents, URS, IQ, OQ, PQ
• →Executing temperature mapping studies
• →Overseeing the execution of Smoke Studies

• Must be willing to work onsite in the Miami metropolitan area
• Bachelor’s Degree or equivalent required
• Specific demonstrable experience leading validation efforts in pharma Clean Room environments
• Demonstrated experience in leading CQV activities specific to Process Equipment
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship