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ERP Validation Engineer

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

ERP CSV LEAD CONSULTANT

We are seeking a highly skilled and experienced SAP CSV Lead Consultant to join a dynamic, global team. As the SAP CSV Lead Consultant, you will play a crucial role in ensuring the compliant and efficient operation of computerized systems, particularly within the SAP environment. This is a fully remote position, offering the opportunity to work from anywhere while contributing to the advancement of innovative medical solutions.

Key Responsibilities:

  • Computer System Validation (CSV): Lead the validation efforts for SAP and other computerized systems, ensuring compliance with relevant regulations, guidelines, and internal quality standards.
  • Validation Strategy: Develop and execute a comprehensive CSV strategy for SAP systems, including risk assessments, validation plans, protocols, and reports.
  • Requirements Gathering: Collaborate with cross-functional teams to gather system requirements, functional specifications, and user needs, ensuring accurate representation in validation documents.
  • Validation Documentation: Prepare and review validation documents, including validation plans, protocols (IQ/OQ/PQ), traceability matrices, validation summary reports, and any necessary deviation documentation.
  • Testing Management: Oversee testing activities, coordinate test execution, and ensure proper documentation of test results, deviations, and issue resolution.
  • Change Control: Lead change control processes related to SAP systems, assessing the impact of changes on validation status and ensuring appropriate revalidation.
  • Risk Management: Identify and evaluate risks associated with SAP systems and propose mitigation strategies to maintain compliance and data integrity.

Qualifications:

  • Bachelor's degree in a relevant scientific or technical field. Advanced degree preferred.
  • Extensive experience (5+ years) in Computer System Validation, with a focus on SAP systems within the pharmaceutical, biotechnology, or medical device industries.
  • Strong understanding of regulatory guidelines such as FDA 21 CFR Part 11, Annex 11, and GAMP 5.
  • Proven experience leading and executing CSV projects, including the development of validation strategies, protocols, and reports.
  • Excellent project management skills, including the ability to manage multiple projects simultaneously and meet deadlines.
  • Strong problem-solving abilities, critical thinking, and attention to detail.
  • Effective communication and collaboration skills, with the ability to work with cross-functional teams and stakeholders.
  • Proficiency in documenting and presenting technical information clearly and concisely.
  • Familiarity with quality management systems and GxP regulations.
  • SAP certification or relevant training in SAP systems validation is a plus.
  • Prior experience working remotely and effectively managing remote teams is an advantage.

Location:

This is a fully remote position. The candidate can work from any location with a reliable internet connection.

If you are a seasoned SAP CSV professional looking for an exciting opportunity to make a significant impact, please apply with your resume and a cover letter detailing your relevant experience and achievements.

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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