MSAT Lifecycle Management Data & Process Specialist (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 61,000 - 66,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a MSAT Lifecycle Management Data & Process Specialist to manage, validate, and deliver manufacturing data across the product lifecycle, partnering with MSAT and cross-functional teams to maintain data integrity and support regulated lifecycle activities.

You will work with data systems, Power BI, and associated tools, perform data verification for regulatory submissions, and help generate data-driven reports while following GMP/cGMP standards and

Qualifications

• Bachelor’s degree in a life sciences or related field.
• 0–2 years of relevant experience or internships.
• Experience in GMP-regulated environments or familiar with data integrity concepts.
• Experience with data systems, data entry, verification, management, analysis or reporting.
• Basic knowledge of Python, SQL or C++ is beneficial.
• Solid understanding of statistics and handling scientific/manufacturing data.

Responsibilities

• Enter, review, verify, and approve manufacturing data across global networks.
• Prepare validated datasets for regulatory submissions and cross-functional requests.
• Support CPV and APQR activities with data management and historical datasets.
• Perform data verification for regulatory submissions and technical documentation.
• Generate metrics and data-driven reports to aid compliance and decision-making.
• Follow GMP/cGMP requirements and internal controls in data handling.

Skills

Attention to detail

Communication

Time management

Team collaboration

Data analysis

Statistical understanding

Education

Bachelor’s Degree in Life Sciences, Biochemistry, Process Chemistry, Manufacturing Sciences & Technology, or related field

Tools

Power BI

Microsoft Office

Python

SQL

C++

Job description

Job Description

The MSAT Lifecycle Management Data & Process Specialist supports the management, validation, and delivery of commercial manufacturing data across the product lifecycle. This role partners with MSAT and cross-functional teams to maintain data integrity, support regulated lifecycle management activities, and ensure accurate and consistent execution of established data processes.

Key Responsibilities

Departmental Data Stewardship & Distribution

• Enter, review, verify, and approve manufacturing data from global internal and external manufacturing networks within validated databases, ensuring information is complete, accurate, and traceable.
• Prepare and provide validated datasets and manufacturing process information to support regulatory submissions, agency responses, technical studies, and routine or ad hoc cross-functional requests.

Lifecycle Management & Regulatory Compliance

• Support Continuous Process Verification (CPV) activities and Annual Product Quality Review (APQR) reporting by managing global manufacturing data and maintaining complete and accurate historical datasets.
• Execute and support Data Verification (DV) activities associated with regulatory submissions, agency information requests, and technical documentation.
• Perform data management activities in accordance with GMP/cGMP requirements, data integrity standards, established procedures, and internal controls.

Process Monitoring & Investigation Support

• Review manufacturing datasets to identify trends, discrepancies, Out-of-Trend (OOT) results, Out-of-Specification (OOS) results, or other potential data or process concerns.
• Support MSAT teams with process trending, technical investigations, CPV-related activities, and cross-functional manufacturing data reviews.
• Generate metrics, summaries, and data-driven reports to support compliance, process monitoring, and departmental decision-making.
• Consistently execute structured and repetitive data processes with a high level of accuracy, organization, and attention to detail.

Digital Innovation & Systems Support

• Work with Microsoft tools, data systems, Power BI, automation or workflow tools, and other digital platforms used to support data management and reporting activities.
• Support continuous improvement and digital initiatives by learning new systems quickly and utilizing automation, AI-based tools, and other technologies where appropriate.

Operational Agility

• Work effectively in a fast-paced, team-oriented environment while managing routine and repetitive activities, adapting to changing priorities, and consistently following established processes.

Job Requirements & Qualifications

Education & Experience

• Bachelor’s Degree in Life Sciences, Biochemistry, Process Chemistry, Manufacturing, Manufacturing Sciences & Technology (MSAT), or a related scientific discipline; Engineering degrees with a Life Sciences concentration may also be considered.
• 0–2 years of relevant professional, internship, co-op, or industry experience; recent graduates with relevant academic experience may be considered.
• Experience or exposure to a GMP-regulated or similarly regulated industry environment.
• Experience working with data systems or performing data entry, verification, management, analysis, or reporting activities.
• Basic knowledge of Python, SQL, C++, or other coding/programming concepts is beneficial.
• General understanding of statistics and comfort working with scientific, technical, or manufacturing data.

Required Knowledge & Skills

• Strong attention to detail with the ability to maintain accuracy while performing structured and repetitive tasks.
• General comfort with digital systems and tools, including Microsoft applications, with the ability to quickly learn new software and internal platforms.
• Strong organizational and time-management skills with the ability to manage a meaningful workload in a fast-paced environment.
• Ability to consistently follow established procedures, work reliably within regulated processes, and adapt to changing priorities.
• Strong communication, collaboration, and team-oriented skills with a willingness to learn and take on new responsibilities.

Contract length: 6 months, with the possibility of extension.

Pay Range

$44/hr. - $48/hr

Shift/Hours

Monday–Friday, Hybrid