Job Description
Pay Range: $45.00hr - $50.00hr
Job Overview:
The candidate will provide hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment. The successful candidate will provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery. The candidate will develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
Responsibilities:
The successful candidate will provide hands-on support for validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.
The candidate will provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.
The candidate's responsibilities include developing, reviewing, and approving validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
The successful candidate will provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.
Requirements:
The candidate should have strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical or manufacturing environments.
The candidate must possess knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.
The successful candidate will have experience reviewing and approving validation documentation and compliance deliverables.
The candidate should have familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.
The candidate should have exposure to one or more manufacturing automation platforms including:
Qualifications:
The candidate must have experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.
The candidate should have a strong understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms.
Benefits:
Our Benefits Include:
Disclaimer : Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
...program/project management. Strategic Planning and Program Growth - This position will lead and drive program growth for the transit, intercity, and freight rail market sectors as well as play an integral role in leading strategic growth across the region. Additional duties...
...Certified Home Health Aides Full time/Part time work available Weekly pay Supportive environment Flexible schedules Sign on bonus Join our growing team of CHHA's Top dollar paid weekly Supportive office staff Flexible schedules Sign on bonus...
...Job Summary Special Education Teacher (2026-27 School Year) - Positions open for Special Education Teachers working with preschool-aged children in Aston and Folcroft (west of Philadelphia). - Schedule: Monday Friday, 8:00 AM 3:30 PM (35 hours/week)....
...weekly pay (inquire for details) Start Date: ASAP About the Position Join a physician-driven, team-oriented group of 15 Internists located 20 minutes west of Eau Claire, WI! This financially strong, outpatient-only practice is partnered with the nation's best...
...Job Description Job Description The Skid Steer Operator at the Whitewater Center will primarily operate a skid steer with the opportunity to operate additional pieces of heavy equipment based on experience and operational need. This includes but is not limited to;...