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Computer Systems Validation Specialist

Computer Systems Validation Specialist

Katalyst Healthcares & Life Sciences

Chapel Hill, NC

Other

Posted 24 days ago

Job description

Roles & Responsibilities:
  • Support implementation of a new MES for drug substance manufacturing operations.
  • Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
  • Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
  • Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
  • Validation and compliance reviews.
  • Ensure project deadlines and quality performance standards are met for all CSV-related activities.
  • Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
  • Review and approve computer systems in the field, including manufacturing and automation systems.
  • Partner with Automation Engineering and system owners to resolve deviations identified during testing.
  • Provide timely responses to management and end users regarding project or system inquiries.
  • Deliver frequent status updates on CSV activities and project progress.
  • Collaborate with project teams, contractors, system owners, and site operations staff.
  • Report key activities and issues to the Senior Manager of Quality Engineering.
Experience Need :
  • 2+ years of MES experience (required).
  • Prior experience with Syncade MES strongly preferred.
  • Hands-on knowledge of CSV within GxP-regulated pharmaceutical manufacturing environments.
  • Ability to work effectively in a fast-paced, open-office setting with frequent distractions.
  • Strong communication skills and ability to work in a matrixed team environment.
  • Ability to coordinate multiple priorities and meet established deadlines.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Computer System Validation Specialist?

A: To succeed as a Computer System Validation Specialist, key technical skills include proficiency in regulatory requirements such as GAMP, 21 CFR Part 11, and ISO 13485, as well as experience with validation methodologies, risk management, and quality assurance principles. Soft skills such as strong analytical and problem-solving abilities, effective communication and collaboration, and attention to detail are also crucial for success in this role. These strengths enable Computer System Validation Specialists to effectively identify and mitigate risks, ensure compliance, and drive quality in the development and implementation of computerized systems.

Q: What is the career path for a Computer System Validation Specialist?

A: A Computer System Validation Specialist typically starts as an entry-level Validation Engineer or Associate, responsible for conducting system audits and testing to ensure compliance with regulatory requirements. As they gain experience, they progress to mid-level roles such as Validation Lead or Senior Validation Engineer, overseeing validation projects and developing validation strategies. Senior-level roles, including Validation Manager or Director, involve leading cross-functional teams, developing organizational validation policies, and ensuring compliance with regulatory standards, providing opportunities for advanced skill development in leadership, project management, and technical expertise.

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Katalyst Healthcares & Life Sciences job posting for a Computer Systems Validation Specialist in Chapel Hill, NC with a salary of $36 to $56 Hourly with a map of Chapel Hill location.