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 - $57Disclosure 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 support their growth and aspirations. 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.
Flex Designation:
On-Site DesignatedFlex 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.
#LI-Onsite
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 [email protected]
Skills Required
- Bachelor's degree, or high school diploma with relevant pharmaceutical or biotechnology manufacturing experience or equivalent education and experience
- Typically one year of experience in a GMP pharmaceutical or biopharmaceutical industry, or equivalent experience
- Familiarity with regulated environments and GMP, GxP, data integrity, or computer system validation concepts
- 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
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
-
Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
-
Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
-
Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
.jpg)
