MES / eBR Engineer – Project Lead

HR Works

JOB DETAILS
SALARY
$95,000–$110,000
SKILLS
Biotech and Pharmaceutical, Computer Skills, Computer Systems, Cross-Functional, Data Quality, Document Management, Drug Manufacturing, ERP (Enterprise Resource Planning), English Language, GMP (Good Manufacturing Practices), Industrial Engineering, Laboratory Information Management System (LIMS), Leadership, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Management, Medical Equipment, Multilingual, Operational Improvement, Operational Strategy, Operations Management, PCI, Project Lifecycle, Project Management Professional (PMP), Project Tracking, Project/Program Management, Regulatory Compliance, Risk Analysis, Risk Management, Spanish Language, Strategic Planning, System Integration (SI), System Validation, Team Lead/Manager, Team Player, Technical Strategy, Validation Plan
POSTED
30+ days ago

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.

About the Company

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