MES / eBR Engineer – Project Lead
HR Works, Barceloneta, Barceloneta, United States
About the Opportunity
Our client, a leading engineering services company in the pharmaceutical industry, is seeking a Project Manager specialized in Digital Manufacturing, with strong experience leading MES / eBR implementations and optimization projects within regulated (GMP) environments.
This role will play a critical part in driving manufacturing digital transformation, improving operational efficiency, and ensuring regulatory compliance.
Key Responsibilities
Lead implementation, upgrade, and optimization projects for MES / eBR systems (e.g., POMSnet, Advance eBR, Enhance PCI)
Manage cross‑functional teams including IT, Quality, Manufacturing, and Validation
Oversee the full project lifecycle: planning, execution, monitoring, and closure
Ensure compliance with GMP and CSV/CSA requirements
Manage project documentation, validation protocols, and deliverables
Identify risks and develop mitigation strategies
Act as the primary liaison between technical teams and business stakeholders
Support broader digital transformation initiatives within manufacturing
Requirements
Bachelor’s degree in Engineering (Industrial, Chemical, Mechanical, Computer, or related field)
5+ years of experience in pharmaceutical or medical device manufacturing environments
Proven experience leading projects involving:
Manufacturing Execution Systems (MES)
Electronic Batch Records (eBR)
Hands‑on experience with at least one of the following systems:
POMSnet
Advance eBR
Enhance PCI
Strong understanding of GMP environments
Experience with Computer System Validation (CSV) or CSA
Demonstrated ability to manage cross‑functional teams and stakeholders
Preferred Qualifications
PMP certification or equivalent
Experience integrating systems (ERP, LIMS, etc.)
Knowledge of data integrity and regulatory compliance
Experience in digital transformation or Industry 4.0 initiatives
Bilingual (English/Spanish)
What We’re Looking For
A highly motivated professional with strong leadership, technical expertise, and strategic thinking skills, capable of translating operational needs into effective digital solutions within a regulated manufacturing environment.
Compensation & Benefits
Competitive salary based on experience
Opportunity to lead high‑impact projects
Exposure to digital transformation initiatives in pharma manufacturing
Collaborative and dynamic work environment
Equal Employment Opportunity (EEO) Statement
Our client is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws.
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Our client, a leading engineering services company in the pharmaceutical industry, is seeking a Project Manager specialized in Digital Manufacturing, with strong experience leading MES / eBR implementations and optimization projects within regulated (GMP) environments.
This role will play a critical part in driving manufacturing digital transformation, improving operational efficiency, and ensuring regulatory compliance.
Key Responsibilities
Lead implementation, upgrade, and optimization projects for MES / eBR systems (e.g., POMSnet, Advance eBR, Enhance PCI)
Manage cross‑functional teams including IT, Quality, Manufacturing, and Validation
Oversee the full project lifecycle: planning, execution, monitoring, and closure
Ensure compliance with GMP and CSV/CSA requirements
Manage project documentation, validation protocols, and deliverables
Identify risks and develop mitigation strategies
Act as the primary liaison between technical teams and business stakeholders
Support broader digital transformation initiatives within manufacturing
Requirements
Bachelor’s degree in Engineering (Industrial, Chemical, Mechanical, Computer, or related field)
5+ years of experience in pharmaceutical or medical device manufacturing environments
Proven experience leading projects involving:
Manufacturing Execution Systems (MES)
Electronic Batch Records (eBR)
Hands‑on experience with at least one of the following systems:
POMSnet
Advance eBR
Enhance PCI
Strong understanding of GMP environments
Experience with Computer System Validation (CSV) or CSA
Demonstrated ability to manage cross‑functional teams and stakeholders
Preferred Qualifications
PMP certification or equivalent
Experience integrating systems (ERP, LIMS, etc.)
Knowledge of data integrity and regulatory compliance
Experience in digital transformation or Industry 4.0 initiatives
Bilingual (English/Spanish)
What We’re Looking For
A highly motivated professional with strong leadership, technical expertise, and strategic thinking skills, capable of translating operational needs into effective digital solutions within a regulated manufacturing environment.
Compensation & Benefits
Competitive salary based on experience
Opportunity to lead high‑impact projects
Exposure to digital transformation initiatives in pharma manufacturing
Collaborative and dynamic work environment
Equal Employment Opportunity (EEO) Statement
Our client is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws.
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