Job Description

Job Description

Job Description

Hello,
We are hiring validation engineer. If you are interested send your resume.

Support the Validation Manager by ensuring effective implementation and maintenance of the Validation program. Serve as a Validation subject matter expert (SME) and track/report action plan status/completion as it relates to validation systems improvement efforts. Responsible for the writing of and the execution of project and system qualifications, validation, and re- qualifications/periodic reviews.

• Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies, clients and Client specifications/requirements.
• Highly experienced with equipment and/or computer system validation.
• Able to assess deviations that affect validation with minimal assistance.
• Able to work with minimal assistance on moderate Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
• Experience with autoclaves and VHP systems.
• Able to speak in audits as a Validation SME.

Qualification :

• 2+ Years Experience
• Bachelor's Degree required
• Need to have CSV computer system validation experience.
• GMP compliance expertise required
• Previous experience with mechanical validation, computer system validation (CSV), change control, CAPAs/deviations, data integrity, and project management required..

 

Thanks

Suchi

203-446-4148

suchi@vastekgroup.com

Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Job Tags

Similar Jobs