Katalyst CRO · 9 hours ago
Project Manager ; Electronic Batch Records (EBR)
Indianapolis, IN
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is overseeing an Electronic Batch Record implementation project. The Project Manager will manage the transition from PMX to the MES Pharma suite, ensuring effective collaboration with SMEs and system configuration teams while presenting project status to site leadership.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
This individual will oversee an Electronic Batch Record (EBR) implementation project that began in Q4 2025
The current Project Manager will provide knowledge transfer and onboarding prior to transitioning out of the role
The site is transitioning from PMX to MES Pharma suite
While the role does not require deep technical expertise, the Project Manager should have a strong understanding of manufacturing operations, including how batch records are executed on the line, signature and approval workflows, and how to partner effectively with SMEs and system configuration teams
The ideal candidate will have a manufacturing or process background rather than a purely IT-focused background
The site consists of 910 process teams, each supporting a minimum of three production lines
Two process teams have already been fully converted, and EBR conversion activities are currently underway (no system upgrades are in scope)
This individual must be comfortable presenting project status and timelines to site leadership during weekly governance meetings
Qualification
Required
A minimum of 5+ years of relevant experience is required
Strong understanding of manufacturing operations, including how batch records are executed on the line, signature and approval workflows
Ability to partner effectively with SMEs and system configuration teams
Comfortable presenting project status and timelines to site leadership during weekly governance meetings
Experience with any MES/EBR platform (e.g., Client-X, Werum, OpsCenter, Syncade) and standard project management tools (e.g., Microsoft Project, Smartsheet)
Preferred
Manufacturing or process background rather than a purely IT-focused background
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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