GxP Operations Support Specialist, Manufacturing Systems

Job Description General

Summary:

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.

Key

Duties and 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.

Knowledge and

Skills:

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

Education and Experience:

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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:$38 - $57

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to…