Safetec of America, Inc. has been your trusted source for infection control, first aid, and compliance products for over 30 years. We are a fast-growing OTC pharmaceutical company located in Buffalo, NY. We are a family-owned, local business with a reputation for retaining employees because we treat them like family.

The Computer System Validation Engineer (CSV) will be responsible for all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will oversee validation activities, develop and approve validation documentation, and risk assessments, work with project teams to resolve elements that should be validated, and conduct impact assessments of proposed changes to computerized systems. The employee will provide vital oversight of system-related issues, utilize risk-based methodology, and ensure that all GxP computerized systems are validated throughout their lifecycle. Additionally, the initiatives focus on providing consistent policy administration, implementing key improvement initiatives, and solving compliance issues.

Responsibilities

• The candidate will be primarily responsible for assisting the Quality and Validation groups with the creation, review, and approval of documents related to CSV of on-site quality systems (ERP, Document Management system, and Training Management system).
• Developing and executing CSV-related documentation, including; system development life cycles, IOPQ, vendor wrapper documentation, and other pharmaceutical system commissioning and validation documentation following current Good Engineering Practices, GAMP, Safetec procedures, industry best practices, and other regulatory-related guidance documents.
• Development of risk assessments related to potential changes to cGMP computer systems and execution of identified action items.
• Providing support to the Quality Assurance and Validation teams in performing, following up with, leading, closing out, and training related to CSV deviations, root cause analysis investigations, and risk assessments.

Qualifications

The ideal candidate will have experience;

• Preparing, reviewing, and executing CSV documents (protocols, reports, procedures, etc.) and procedures for GMP control of computerized systems.
• Preparing, reviewing, and approving change controls
• Auditing CSV documentation and infrastructure to ensure compliance and alignment with FDA and regulatory requirements
• Writing technical documentation and methodology reports
• Working directly with cross-functional teams (engineering, quality assurance, IT, operations, etc.) to develop and support computer system processes.

The ideal candidate will have a strong understanding of;

• cGMPs in pharmaceutical/biotechnology or related industries.
• GAMP 5, 21 CFR Part 11, Annex 11, and computer system validation methodologies.
• Software development and software lifecycle management in alignment with QA methodologies
• Industry standards for cGMP automation and computerized systems and quality assurance methodologies
• Thorough understanding and knowledge of industry standards and best practices for computer system validation

Education/Experience

• Bachelor's degree in science or related technical field
• 5+ years of demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas in the pharmaceutical/biotech industry 2+ years of computer system validation experience