GxP Operations Support Specialist, Manufacturing Systems

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 52,000 - 79,000; Full time

Job summary

Vertex Pharmaceuticals Inc. is seeking a GxP Operations Support Specialist to help implement and maintain digital manufacturing systems.

You will collaborate with Manufacturing, Quality, Engineering, and IT to document processes, test changes, and ensure compliant operations.

In this on-site role, you will support MES deployments, user testing, training, and documentation, while analyzing data to drive continuous improvement and strengthen GMP compliance.

Qualifications

• Bachelor’s degree or equivalent experience in pharmaceutical/biotech manufacturing.
• Typically requires 1 year of GMP pharma/biopharma experience.

Responsibilities

• Configure, test, and deploy MES and system changes.
• Support UAT, create test cases, track defects, coordinate resolutions.
• Maintain system- and process-docs, SOPs and work instructions.
• Monitor incidents and coordinate with support teams.
• Develop understanding of GMP, GxP and MES best practices.

Skills

Documentation

Analytical thinking

Cross-functional collaboration

Fast learner

GMP/GxP familiarity

Education

Bachelor's degree

High school diploma with pharma experience

Tools

MES

Test management

Document management systems

UAT testing

Job description

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.

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.

Flex Designation

On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Benefits

• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.