Senior Automation Computer Systems Validation Engineer/Automation Computer Systems Validation

Are you looking for an opportunity to manage validation projects for computer systems cross functionally? If so, this is the job for you.

The Computer Systems Validation (CSV) Engineer in the Automation Team is responsible for ensuring that all computer systems and software applications used in the automation of manufacturing processes are validated in accordance with regulatory requirements and industry standards. This role involves close collaboration with cross-functional teams, including IT, Quality Assurance, and Manufacturing, to implement and maintain validated systems that support the production of high-quality pharmaceutical products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Develop and maintain validation plans, protocols, and reports for computer systems used in automation.
• Execute validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure validation documentation complies with regulatory requirements (e. g. , FDA, EMA) and GSK's quality standards.
• Conduct risk assessments to identify potential issues related to computer systems and software.
• Implement risk mitigation strategies to ensure system reliability and compliance.
• Monitor validated systems to ensure continued compliance and performance.
• Perform periodic reviews and re-validation activities as necessary.
• Manage change control processes for validated systems.
• Work closely with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure alignment on validation requirements and activities.
• Provide technical guidance and support to team members and other departments regarding CSV best practices.
• Develop and deliver training programs related to computer system validation and regulatory compliance.
• Stay current with industry trends, regulatory updates, and best practices in CSV and automation.
• Maintain accurate and detailed records of validation activities.
• Prepare and present validation reports and documentation to regulatory agencies during audits and inspections.

• Associates degree in Computer Science, Engineering Technology, Automation and Controls Systems OR industry-recognized certifications, such as those offered by ISPE (International Society for Pharmaceutical Engineering) or ASQ (American Society for Quality)
• 3 years of experience in computer systems validation within the pharmaceutical or biotechnology industry.
• 3 years' Experience with automation systems and software used in manufacturing processes.

• Ability to analyze data to identify trends, root causes of issues, and opportunities for improvement.
• Strong problem-solving skills to diagnose and resolve complex technical issues effectively.
• Meticulous attention to detail to ensure all validation, automation, and technical support documentation is accurate and complete.
• Ensuring that all processes and systems meet rigorous quality standards and regulatory requirements.
• Ability to clearly communicate technical information to non-technical stakeholders.
• Strong interpersonal skills to work effectively with cross-functional teams, including IT, engineering, quality assurance, and production.
• Willingness and ability to learn new technologies and methodologies as the industry evolves.
• Ability to adapt to changing priorities and work in a fast-paced environment.
• Ability to prioritize tasks effectively to manage multiple projects and deadlines simultaneously.
• Efficiently managing time to ensure timely completion of validation activities, technical support, and project milestones.
• Knowledge of relevant software and tools used in validation, automation, and technical support (e. g. , validation software, automation tools, data analysis programs).
• Understanding of industry standards and best practices in pharmaceutical manufacturing and automation.
• Ability to work collaboratively within a team to achieve common goals.

• Bachelor's degree in engineering
• 5 years of experience in computer systems validation within the pharmaceutical or biotechnology industry.
• 5 years' Experience with automation systems and software used in manufacturing processes.

• Ability to analyze data to identify trends, root causes of issues, and opportunities for improvement.
• Strong problem-solving skills to diagnose and resolve complex technical issues effectively.
• Meticulous attention to detail to ensure all validation, automation, and technical support documentation is accurate and complete.
• Ensuring that all processes and systems meet rigorous quality standards and regulatory requirements.
• Ability to clearly communicate technical information to non-technical stakeholders.
• Strong interpersonal skills to work effectively with cross-functional teams, including IT, engineering, quality assurance, and production.
• Willingness and ability to learn new technologies and methodologies as the industry evolves.
• Ability to adapt to changing priorities and work in a fast-paced environment.
• Ability to prioritize tasks effectively to manage multiple projects and deadlines simultaneously.
• Understanding of industry standards and best practices in pharmaceutical manufacturing and automation.
• Demonstrated ability to lead projects or initiatives, mentor junior team members, and contribute to a positive team environment.