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Senior Validation Engineer/Analyst

4 months ago

Coral Gables, United States Catalyst Pharmaceuticals Full time

The Senior Validation Engineer works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is primarily an individual contributor, reporting to the Associate Director, Manufacturing Systems Engineering. The Senior Validation Engineer will work with Business Owners, System Owners, Quality, and suppliers to create, manage, and improve computerized systems validation deliverables for electronic data to maintain data integrity while supporting ALCOA+ principles throughout the validation lifecycle. The CSV Senior Engineer will have responsibility to ensure the validation of electronic systems and applications are documented in accordance with the relevant Catalyst procedures and regulations and works to improve CSV/CSA and GxP data management processes (including SOPs, WIs, etc.) for greater control and efficiency.

This position is primarily in-office but open to remote candidates who meet the necessary qualifications and possess excellent communication and collaboration skills.

Responsibilities:

  • Author, execute, review and/or approve applicable CSV documentation. Prepare final reports and assembly of final validation packages.
  • Execute applicable system test scripts as well as address deviations & incidents.
  • Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Consults the Validation Lead and contributes to defining the Validation Plan, Validation Strategy and Requirements to ensure compliance with regulatory requirements and standards.
  • Conduct impact assessments for changes related to validated computerized systems and initiate IT Change Controls.
  • Author the documentation (SOP/WI/Policies) authoring and development with the support of the Business Lead and Validation Lead.
  • Identifies the applicable validation regulatory requirements, laws, standards, and best practices applicable to the project such as GAMP5, 21 CFR Part 11.
  • Additional responsibilities as assigned.

Education/Experience/Skills:
  • B.S. in Engineering or Technical Field
  • 5+ years of direct experience in validation within the pharmaceutical industry.
  • Strong functional knowledge of quality systems records (Deviations, CAPAs, Change Requests, SOPs) and related activities.
  • Familiar with development and execution of CSV documentation (Validation Plans, Requirements, Design/Configuration Specifications, Test Scripts (IQ/OQ/PQ), Summary Reports).
  • Strong technical acumen with computer systems function and architecture.
  • Strong interpersonal skills to help ensure that working relationships are developed and maintained between the many internal and external stakeholders.
  • Proficient computer skills including Microsoft Office applications.
  • Effective written and oral communication.
  • High level of attention to detail.
  • Serialization (DSCSA) experience, specifically with the TraceLink system. (Preferred)
EEO Statement

At Catalyst Pharmaceuticals, Inc., we value a diverse, inclusive workforce and provide equal employment opportunities for all applicants and employees. It is our company's commitment to ensure qualified applicants for employment will be considered without regard to an individual's race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran, or any other basis protected by federal, state, or local laws.

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.