Senior Validation Consultant

hace 2 semanas

Ciudad de México, Ciudad de México ConvaTec Inc. A tiempo completo

ConvaTec Inc. is a global leader in medical products and technologies, dedicated to improving the lives of people around the world. We are seeking a highly skilled Senior Validation Consultant to join our team.

About Us

We are a company with a rich history of innovation and commitment to quality. With a presence in almost 100 countries, we provide our products and services to millions of people every day. Our mission is to be forever caring, and we strive to deliver solutions that make a real difference in people's lives.

As a Senior Validation Consultant at ConvaTec Inc., you will play a critical role in ensuring that our computerized systems meet the highest standards of quality and compliance. You will work closely with our project teams to design, develop, implement, and validate computerized systems that support our healthcare products.

About the Role

We are offering a competitive salary of $120,000 per year, plus benefits and opportunities for professional growth and development. As a Senior Validation Consultant, you will have the opportunity to work on complex projects, develop your skills and expertise, and make a meaningful contribution to our organization.

Key Responsibilities
  • Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on risk-based validation approaches.
  • Work closely with project managers to ensure all compliance milestones are met during the project lifecycle.
  • Oversee and assist in the development of validation deliverables, including validation plans, test plans, protocols, scripts, specifications, and design documents.
  • Prepare and review major system documentation to ensure consistency with quality standards and quality of deliverables.
  • Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use, and maintenance of computerized systems.
  • Coach implementation teams in the proper execution of validation documents.
  • Manage formal testing of computerized systems, including setup, documentation, approval, delivery, and test reporting.
  • Solve problems during the validation process and address issues such as deficiencies, deviations, and change controls.
Requirements
  • A good engineering background with a focus on equipment/process validation.
  • Understanding of equipment controlled by PLC as part of a production line.
  • 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.
  • Detailed understanding of equipment/process validation.
  • Experience in electronic software applications such as EDMS, PLM, QMS, LIMS, Complaint Management Systems, ERP, etc.
  • Ability to rapidly adapt to new situations and environments.
  • Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
  • Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
  • Ability to handle a high concentration of work through successful multitasking and prioritizing.
Qualifications/Education

Bachelor's degree in computer science, engineering, life science, or related field, plus at least 2 years' experience with equipment/process validation lifecycle management, validation documentation development. 2+ years' pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA, or compliance functions. Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills.

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