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Senior CSV Project Manager

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 Senior Computer System Validation Project Manager for a remote opportunity.
 
Objectives of this Role:
 
  • Drive overall quality performance and compliance throughout the global organization by defining, implementing and maintaining the CSV program.
  • Build CSV project schedules, track deliverables, update stakeholders and ensure projects stay within budget.
  • Review existing CSV reports and identify gaps for GMP, and regulatory compliance. 
  • Develop strategies and plans to close the gaps in an efficient and technical manner.
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
  • Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
  • Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create CSV reports. 
  • Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels.
  • Coordinate with end users and process owners to lead development of CSV protocols.
  • Participate in project management meetings as Validation representative determining CSV requirements as needed.
  • Learn and understand the applicable technology and engage in technical discussions.
  • Identify areas and opportunities to improve CSV in facilities, processes and equipment.
  • Provide consultation to other departments performing CSV activities.
  • Ensure validation program meets requirements of FDA (21 CFR Part 11) and ISO.
     
Skills and Qualifications:
 
  • Bachelor’s degree in computer science, IT, or comparable education/experience.
  • A minimum of 7 years’ experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment.
  • Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP).
  • 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.
  • Must be a self-starter with great team communication skills.
  • Must have proven ability to lead a team.
 
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.
•Paid holidays.
•Other great incentives.

Company Response to Covid-19
While we serve industries that are 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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