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Validation Engineer
4 months ago
Job Description
Job Description
Job Overview :
The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes.
Responsibilities :
Write and Develop
Equipment/Facility/Utility
and Instrument Qualification protocols, as well as
Validation/Qualification
Policies.
Initiate Change Controls - provide validation assessments and remediation plans as required by the
system/equipment/components.
Develop Commissioning and Qualification Plans.
Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211, as well as adherence to ICH Q7.
Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
Assure Compliance with FDA and EU Regulations.
Evaluate, document, and develop investigations attributed to qualifications failures.
Author Summary Reports, events, and applicable protocol amendments.
Execute and/or provide support during protocol executions.
Assure all the qualification items are tracked and successfully completed.
Perform GAP analysis and provide recommendations for existing qualifications.
Validation/Qualification
activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)
Preferred/Required Education/Skills :
Bachelor’s or Master's degree in Engineering, Science, or a related field.
3+ years of experience with commissioning, validation and qualification of
Equipment/Facilities/Utilities
and Processes using Risk Based approach and leverage strategies. Temperature mapping is a plus
Pharmaceutical, healthcare, or medical device industry experience is a plus
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
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