Katalyst CRO ยท 4 days ago
Sr.MES Consultant
Boston, MA
Contract
Onsite
Senior Level, Lead/Staff
10+ years expKatalyst CRO is seeking a Senior MES Consultant with extensive experience in the Manufacturing and Medical Device domain. The role involves collaborating with project teams and customers for requirement gathering, master data modeling, and producing technical documentation.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc
Previous work experience in MES implementation using any platform
Must have hands-on experience on testing tools like Client ALM, Polarion etc
Excellent English skills, both spoken and written
Collaborate as a project team member and directly with customer on requirement gathering, master data modelling and enrichment, giving Demos on core and new concepts to SMEs and End users
Working collaboratively and helping cross-cultural and cross-regional team members - both internal and on customer side
Develop and produce technical reports, process flow diagrams and documentation in support of design and developments
Qualification
Required
Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc
Previous work experience in MES implementation using any platform
Must have hands-on experience on testing tools like Client ALM, Polarion etc
Excellent English skills, both spoken and written
Collaborate as a project team member and directly with customer on requirement gathering, master data modelling and enrichment, giving Demos on core and new concepts to SMEs and End users
Working collaboratively and helping cross-cultural and cross-regional team members - both internal and on customer side
Develop and produce technical reports, process flow diagrams and documentation in support of design and developments
10+ years of MES experience in Manufacturing and Medical Device Domain (MDD)
5+ years of working experience in managing Critical Manufacturing MES implementations and Rollouts, master data modelling and enrichment
Certified Critical Manufacturing Professional / Associate: Modeler
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
Represents job field similar to this job
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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