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Computer System Validation Specialist

Raleigh-Durham, NC
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
 
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Computer System Validation Specialist for a remote opportunity. 
 
Objectives of this Role:
  • Preparation of Validation protocols for GxP critical reports.
  • Assist in protocol execution, review and approval.
  • Generation of Change requests and IT tickets for the validation of reports.
  • Validation of business intelligence reports and skilled with all the tests required to properly qualify the reports.
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects.
  • Develop and execute documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include URS, FRS, FRA, HLCCD, etc.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control, etc.
  • Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP/GLP/GAMP/GALP).
  • Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports.  Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
  • Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.
  • Attend meetings to assist in the development of a validation remediation strategy.
 
Skills and Qualifications:
  • Bachelor’s degree in business/technical area or comparable education/experience.
  • A minimum of 5 years’ experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and execution of IOQ/PQ’s, experience in performing traceability matrices, risk assessments.
  • Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP).
  • Must have strong hands-on, end-to-end CSV project experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management. 
  • Solid understanding of data integrity risks.
  • Ability to manage complex projects and timelines in a matrix team environment.
  • Ability to independently identify compliance risks and escalate when necessary.
 
 
Why PharmEng Technology? 
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
 
What We Have:
 
  • Comprehensive benefits package & competitive wages
  • A supportive environment where employee growth is promoted
  • PTO & paid holidays
  • Other great incentives
 
Company Response to Covid-19
While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.
 
EEOC Statement
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
 

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