Senior Validation Professional

hace 1 día

Xico, México Convatec Inc. A tiempo completo

About Convatec Inc.

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Convatec Inc. is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.

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Job Overview

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We are seeking an experienced Senior Validation Professional to join our team. As a key member of our validation team, you will play a critical role in ensuring that all computerized systems meet regulatory requirements and are compliant with industry standards.

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Your Responsibilities

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You will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems. Your responsibilities include:

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  • Evaluating proposed new computerized systems or software to assess GxP impact and providing guidance on the risk-based validation approach for the system.">
  • Working closely with project managers to ensure all compliance milestones are met during the project lifecycle.">
  • Developing validation deliverables including validation plans, test plans/protocols/scripts, specifications, and design documents.">
  • Reviewing and approving major system documentation to ensure consistency with quality standards and quality of deliverables.">
  • Establishing and maintaining standards and training materials for the specification, design, development, configuration, implementation, validation, use, and maintenance of computerized systems.">
  • Coaching implementation teams in the proper execution of validation documents.">
  • Managing formal testing of computerized systems, including setup of testing, documentation, approval, delivery, and test reporting.">
  • Solving problems during validation processes and addressing issues such as deficiencies, deviations, and change controls.">
  • Ensuring initiation/preparation and closeout of all eCSV related deviations.">
  • Supplying accurate KPIs to management on project compliance status.">
  • Reviewing proposed changes to validated computer systems/qualified IT infrastructure and identifying validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.">
  • Performing periodic assessments to review and confirm validated status.">
  • Ensuring all changes are implemented and documented in a compliant manner.">
  • Maintaining up-to-date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems.">
  • Acting as an information resource for delivery teams and wider business.">
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Requirements

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To succeed in this role, you will need:

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  • ">
  • A good engineering background with a focus on equipment/process validation.">
  • An understanding of equipment controlled by PLC as part of a production line.">
  • A strong understanding of GXP Regulations and best practices (21 CFR 820, 21 CFR 11, Annex 11, GAMP, etc.).">
  • Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements for computerized systems supporting healthcare products.">
  • A detailed understanding of equipment/process validation.">
  • Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Laboratory Information Systems (LIMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.">
  • Excellent communication skills with the ability to effectively convey compliance requirements at all levels.">
  • The ability to influence, negotiate, and constructively challenge to achieve productive solutions.">
  • The ability to handle a high concentration of work through successful multitasking and prioritizing.">
  • Conscientiousness and a high level of commitment, with a dedication to quality.">
  • A Bachelor's degree in Computer Science, Engineering, Life Science, or a related field, plus at least 2 years' experience with equipment/process validation lifecycle management, validation documentation development.">
  • At least 2 years' pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA, or compliance functions.">
  • Excellent presentation and writing skills.">
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Estimated Salary: $120,000 - $180,000 per year

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Benefits

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We offer a competitive salary package, comprehensive benefits, and opportunities for professional growth and development.

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About Us

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Convatec Inc. is a global medical products and technologies company dedicated to improving the lives we touch. We are united by a promise to be forever caring and strive to make a positive impact on people's lives worldwide.

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How to Apply

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If you are a motivated and experienced professional looking for a challenging role, please submit your application, including your resume and cover letter, to our careers portal.

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Contact Information

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Please note that we do not accept unsolicited referrals or speculative applications. Our recruitment process is managed through our careers portal, and we appreciate your cooperation in adhering to this policy.

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