Dawar Consulting, Inc.

Support lifecycle management, validation, and compliance activities for GMP-regulated manufacturing systems, including documentation, audits, and system upgrades. | Requires 5+ years in Computer System Validation within regulated industries, with knowledge of GAMP, FDA 21 CFR Part 11, and experience with ISA-95 systems. | Our client, a world leader in diagnostics and life sciences, is looking for a " Senior Validation Specialist” based out of Hillsboro, OR. Job Duration: Long term Contract (Possibility Of Further Extension) Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K We are seeking an experienced IT/OT Computer System Validation (CSV) Engineer to support lifecycle management, validation, and compliance activities for GMP-regulated manufacturing systems. This role will work closely with System Owners to ensure validated state, data integrity, and regulatory compliance for Level 2 and Level 3 ISA-95 systems. Key Responsibilities Support lifecycle management of IT/OT systems including validation, maintenance, testing, and documentation Author, review, and execute validation documents (URS, FRS, IQ, OQ, PQ, risk assessments, periodic reviews) Perform annual maintenance (MILE) activities and system periodic reviews Own and manage Quality records including CAPA, Deviations, and Planned Events Conduct audit trail reviews, account reviews, and system compliance checks Support upgrades, patching, and system changes ensuring GMP compliance Collaborate with global and local stakeholders on validation and compliance activities Generate quality metrics and attend Quality Huddle meetings Maintain documentation in EDMS platforms (Veeva, Condor, eVal, etc.) Required Qualifications Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field 5+ years of experience in Computer System Validation (CSV/CSA) within the pharmaceutical or regulated industry Strong knowledge of GAMP, FDA 21 CFR Part 11, Annex 11, GxP, and Data Integrity principles Experience supporting Level 2 and Level 3 ISA-95 systems Hands-on experience with validation protocol authoring and execution Preferred Experience Experience with DeltaV, OSI-PI, MES, SCADA, Siemens Desigo, Rockwell FactoryTalk PharmaSuite, BAS Understanding of ISA-95 framework Experience managing CAPA, Deviations, and Change Control processes If interested, please send us your updated resume at hr@dawarconsulting.com/kavitha@dawarconsulting.com

Oversee contact center operations, vendor relationships, and drive continuous improvement through digital solutions. | Proven experience in medical contact center operations, compliance, vendor management, and digital CRM systems, with a relevant degree. | Our client, a world leader in biotechnology and life sciences, is looking for a "US Medical Contact Center Oversight and Strategy Lead (100% Remote)”. Job Duration: Long Term Contract (Possibility Of Extension) Pay Rate : $80/hr - $95/hr on W2 DOE Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Duration: Long term contract (Possibility of further extension) The US Medical (USM) Contact Center is a key customer interface, delivering critical medical information and trial information support to HCPs, patients, and population-based decision makers. This role is responsible for overseeing a contact center vendor and ensuring operational excellence while advancing the contact center through continuous improvement, innovation, and alignment with an evolving portfolio. Key Responsibilities · Lead vendor governance, performance oversight, and SLA/KPI management · Ensure audit readiness and compliance with GCP, GVP, and regulatory standards · Oversee budgeting, forecasting, SOWs, and operational resource planning · Drive contact center evolution through AI, automation, and multi-channel digital solutions · Serve as primary point of contact for vendor relationship and issue resolution · Implement continuous improvement and advanced analytics to enhance customer experience Required Qualifications · Proven experience overseeing medical contact center operations in pharma/biotech · Strong knowledge of compliance and regulatory requirements · Expertise in vendor management, performance analytics, and service delivery · Ability to lead complex, cross-functional projects in a matrixed environment · Experience with digital CRM systems Education · Bachelor’s degree preferred (business, life sciences, or related field) · MBA or graduate degree preferred If interested, please send us your updated resume at hr@dawarconsulting.com/akansha@dawarconsulting.com