MSAT Lifecycle Management Data & Process Specialist (Contract)

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.

• 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.

• 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.

• 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.

• 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.

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

• 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.

• 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.