Position Summary
This role is responsible for leading validation and lifecycle activities for automated and computerized systems within a regulated pharmaceutical or biotechnology manufacturing environment. The individual will ensure systems that support operations, laboratory functions, and business processes meet applicable regulatory and quality requirements while supporting continuous improvement and technology advancement.
Primary Responsibilities
Validation & Automation
Develop and execute validation approaches for automated and computerized systems using risk-based methodologies and current industry best practices.
Perform system risk assessments and support strong data integrity practices throughout system lifecycles.
Generate, review, and maintain validation lifecycle documentation and support system qualification activities.
System Lifecycle & Change Management
Lead implementation, enhancement, and change management activities for systems supporting GxP-regulated processes.
Partner with cross-functional teams to maintain systems in a compliant and controlled state.
Regulatory & Compliance Support
Ensure activities align with applicable regulatory guidelines and internal quality expectations.
Support audits and inspections by providing documentation and technical expertise related to system validation and controls.
Continuous Improvement & Innovation
Identify opportunities to enhance efficiency and performance through improved automation, data utilization, and digital solutions.
Contribute to broader initiatives focused on process improvement and operational excellence.
Quality Collaboration
Work closely with quality and technical stakeholders to ensure validation deliverables and system changes meet applicable requirements.
Provide input during system implementation and qualification to support compliant outcomes.
General Expectations
Deliver accurate, high-quality work aligned with project timelines.
Foster a collaborative and professional work environment.
Support additional responsibilities as needed.
Technical Skills & Core Competencies
Advanced knowledge of automation technologies and computerized system validation (CSV/CSA) principles, along with a strong understanding of industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
Proven ability to lead projects and coordinate activities across multiple functions in a regulated environment.
Strong technical writing skills with the ability to produce clear, accurate, and compliant documentation.
Experience working with enterprise quality, maintenance, laboratory, manufacturing, and business systems in regulated environments.
Familiarity with industrial automation and manufacturing technologies and their application within validated systems.
Familiarity with emerging digital technologies and advanced analytics tools used to support compliant business processes.
Strong analytical, troubleshooting, and problem-solving abilities.
Ability to manage multiple priorities while maintaining attention to detail and compliance standards.
Education & Experience
Bachelors degree in Engineering, Computer Science, Pharmaceutical Sciences, or a related technical field (required).
Advanced degree preferred.
Minimum of 8 years of experience in automation, computerized system validation, or related disciplines within a regulated environment.
Experience within pharmaceutical or biotechnology manufacturing environments is preferred.
Strong understanding of risk-based validation approaches and data integrity principles.
Work Environment
Primarily office-based with interaction across technical and operational teams.
Flexibility to work extended hours based on business needs.