GxP Operations Support Specialist, Manufacturing Systems

Vertex Pharmaceuticals•Boston, MA

9d•Onsite

About The Position

The GxP Operations Support Specialist will support the implementation, maintenance, and continuous improvement of digital manufacturing systems. Working under the guidance of more senior team members, this role will partner with Manufacturing, Quality, Engineering, and IT stakeholders to document business processes, support system enhancements, test system changes, and help ensure reliable and compliant system operations.

Requirements

Strong attention to detail and ability to create accurate, organized documentation.
Demonstrated problem-solving, analytical, and communication skills.
Ability to learn new technologies and business processes in a fast-paced, collaborative environment.
Ability to work effectively with cross-functional teams and manage assigned work with appropriate guidance.
Familiarity with regulated environments and concepts such as Good Manufacturing Practices (GMP), GxP, data integrity, or computer system validation.
Bachelor’s degree or high school diploma with experience in a pharmaceutical or biotechnology manufacturing or the equivalent combination of education and experience in a related field.
Typically requires 1 year of experience in a GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.

Responsibilities

Help configure, test, and deploy MES and other system changes under the direction of senior team members, system owners, and technical teams.
Participate in workshops and meetings with Manufacturing, Quality, Engineering, Supply Chain, and IT stakeholders.
Support user acceptance testing (UAT), including preparing test cases, documenting test results, tracking defects, and coordinating issue resolution.
Assist with documentation, including requirements, test evidence, and change-control records.
Support manufacturing digital system operational activities, including monitoring incidents, documenting issues, escalating concerns, and coordinating with support teams.
Help maintain system and business-process documentation, including standard operating procedures, work instructions, training materials, and process maps.
Assist with end-user communications and training activities related to MES enhancements and system releases.
Analyze basic system, production, and issue-management data to identify trends and support continuous improvement initiatives.
Develop a working understanding of manufacturing operations, electronic batch records, GxP requirements, and MES best practices.
Perform other system-analysis and project-support activities as needed.