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Description:

Validations Specialist Commissioning and Qualification

Responsibilities:
Reports on progress and roadblocks to the project team.
Develop relevant protocols, execute protocols, and own C&Q activities for the decommissioning project for the commercial QC lab in San Diego
Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and end of life periodic reviews
Liaise with client end user groups to ensure project is successfully completed per industry and Our Client guidelines.
Validation using risk-based approach (FMEA, PHA, etc.)
Authors and reviews project documentation, as needed. (URS, FRS, Technical Specifications, Functional Specifications)
Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information
Partners with Quality to ensure a quality and compliant environment
Other related duties as assigned.

Requirements:
Bachelor's degree in Engineering, Science or related technical field.
4+ years of experience in pharmaceutical or biotechnology GMP manufacturing performing commissioning and qualification (C&Q) or equipment validation activities.
Ability to read/interpret engineering drawings and design documents
Excellent technical writing and verbal communication skills
Must be able to work independently and successfully plan to
Must be people oriented and a team player
Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211
Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements