CSV Engineer

Job Description:
Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and
support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team.
Responsibilities:

• Conduct thorough reviews of validation documents.
• Assist in the creation and development of validation deliverables.
• Adapt to and excel in a dynamic and challenging work environment.
• Clearly articulate the significance of validation processes to non-specialist audiences.
• The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of Client's vendors and computerized systems.
• Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls.
• Review CAPA and verification of CAPAs of system and vendor audits.
• QA approver for internal validation efforts.
• Act as liaison to the business for guidance and consultancy on software validation.
• Support health authority audits/inspections for inspection readiness.

Requirements:

• Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.
• Software development familiarity with both Agile and Waterfall methodology.
• Minimum 3-5 years' experience in pharmaceutical industry or similar.
• Minimum 1-3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience.
• Knowledge of regulations governing software validation and development.
• Knowledge of Google Cloud Platform/GMP is preferred.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Ability to Travel.

Note:

• Hybrid - must be a local candidate willing to come on site - 2-3 days a week in Nutley.