Senior Validation Engineers

Full Time
India, USA
Posted 7 months ago

No of Positions: 2 (1 in US and 1 in Hyderabad)

Location: US opening is a remote position.

Hyderabad opening is onsite work from Hyderabad Pharma Tek Office location.

Job Description: Pharma Tek Solutions is currently looking to hire Senior Validation Engineers will over 8 years of experience with following expertise:

Provide leadership in discovery sessions with our clients as required. Work with customers to understand business processes and challenges and recommend solutions that leverage Pharmatek’ s services to meet their needs. Participate in analysis and mapping of customer requirements.

Experience working in Regulated and non-regulated environments of major Biotech and Pharmaceutical companies with a thorough understanding of FDA GxP regulatory and quality requirements for software and computer systems.

Validating computer systems to make sure they are following FDA regulations.

Create all Computer System Validation/ Software Development Life Cycle Deliverables required to implement the system (Validation plan, Validation summary reports, User Requirements, Specifications, Risk Assessments, IQ, OQ and PQ, Traceability Matrix, Release Notes, Deviations)

Sound knowledge and good understanding Software Test Life Cycle (STLC) and Defect Life Cycle

Performing Computer System Validation on Legacy and Prospective non-product software

applications

Experience in GCP Systems like EDC, IRT, SAS, eTMF, Veeva CRM and Veeva Vault products, EDMS, LMS, and QMS systems

Experience in Compliance (Annex 11, 21 CFR Part 11, GAMP5 guidelines)

Experience in Performing Periodic Reviews and Audit Trail Reviews

Manage customers and provide support during implementation and post go-live.

Enable change management at the customer, based on change management recommendations.

Lead training sessions to ensure all the system end users understand the system.

Support clients through go-live process and play key role in promoting solution adoptions.

Participate in weekly status meetings with Project Managers and other key stakeholders.

Self- motivated with ability to handle, organize and prioritize multiple tasks in a dynamic high-volume work environment.

Work in Quality Assurance process awareness and adherence. Must have experience in supporting preparation/review process related documents like SOP’s (Standard Operating procedures), Work Instructions (WIS) for the Support process.

Participate in Internal and External Process Audits for the Support process.

Perform manual testing of the scenarios reported by end users as support tickets, reproduce them for internal technical/functional teams understanding and resolution purpose and test any future release builds.

Qualification: Bachelor’s degree in computer science engineering or master’s degree in computer applications or equivalent

If interested, please send resumes to hr@pharmateksol.com

Job Features

Job CategoryValidation Engineer

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