Vacancy expired!
Job Description
Responsible for the planning and execution of the C&Q program from start to finish according toclientprocedures and practices and according to the project verification plan
Work closely with stakeholders in a team that includes equipment suppliers, operations, automation, technology, quality, and maintenance personnel
Execute the project C&Q master plans, identify task lists and timelines for their respective packages in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate road blocks
Support C&Q planned activities including risk assessment, design reviews / DQs, test matrices, FATs, SATs, commissioning, installation, operational and performance verification for all systems as applicable
Prepare and execute verification protocols
Actively participating verification phase improvement (lessons learned, deviation management and resolution, etc.)
Responsible for respective packages C&Q documentation development and management and quality of the turnover documentation package
Attend all required training on GMP, EHS,clientstandard and protocol implementation in time
Regular updates, and progress reports and reviews with the C&Q manager
Manage and close major deviations for respective systems (punch list and exceptions list)
Developthe Qualification Summary Report for respective systems, reviews and comments on the assembly and the handover of respective systems’TOPs
Qualifications
Bachelors degree in Engineering or Science
Able to work in construction, production, and packaging areas
Strong analytical and communications skills are required
Excellent written and verbal presentation skills
Experience in C&Q of pharmaceutical and /or Medical Device environment
Minimum 3 years’experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach
High level of familiarity with Excel, Word, Access, and Microsoft Project
Ability to work in a fast-paced environment
Additional Information
Validation and Engineering Group, Inc.is an Equal Employment Opportunity employer.Vacancy expired!