X4 Engineering · 14 hours ago
Senior MES Engineer
United States
Contract
Remote
Senior Level
7+ years expX4 Engineering is a 100% employee-owned engineering and automation firm with over 40 years of industry experience. They are seeking an experienced Senior MES Engineer to lead the design, configuration, and deployment of Manufacturing Execution System (MES) solutions within the Life Sciences industry.
Staffing & Recruiting
Hiring Manager
Darragh Glynn
Responsibilities
Act as MES solution architect, leading the design, implementation, and validation of MES systems
Develop MES strategies that integrate process knowledge, equipment automation, and information technology to improve efficiency and compliance
Manage full project lifecycles - from design through commissioning - including budgeting, scheduling, and financial control
Identify and document client requirements, develop design specifications, and coordinate system integration from Level 2 (automation) to Level 4 (ERP)
Lead and mentor engineering teams, ensuring successful delivery of MES projects up to $1M in scope
Establish and enforce engineering standards and best practices for MES solution development
Drive continuous improvement initiatives and promote innovation across projects
Qualification
Required
Bachelor's degree in Engineering, Computer Science, or Applied Sciences
7+ years of experience implementing MES solutions within regulated industries
Hands-on experience with leading MES platforms (e.g., Pharmasuite, PAS-X, Syncade, Apprentice, Sepasoft, or POMS)
In-depth knowledge of GAMP5, ISA-88 (S88), and ISA-95 (S95) standards
Familiarity with FDA/cGMP compliance, including 21 CFR Part 11
Proven experience integrating MES systems with ERP, SCADA, Historian, LIMS, QMS, and CMMS
Proficiency in SQL or Oracle databases and historian/reporting technologies
Strong leadership, communication, and technical documentation skills
Ability to travel up to 25% as required
Preferred
Experience in the Life Sciences (pharmaceutical or biotech) sector
Demonstrated ability to manage cross-functional project teams
Strong organizational and problem-solving skills with a business-minded approach
Benefits
Comprehensive Medical, Dental, and Vision coverage
Life and Disability insurance options
Flexible Spending and Health Savings Accounts
Paid Time Off (PTO) and holidays
401(k) with profit sharing
Employee Stock Ownership Plan (ESOP)
Tuition reimbursement, referral bonuses, and employee assistance programs
Company
X4 Engineering
X4 Engineering partner with businesses across the entire engineering spectrum, from early-stage R&D to commercial enterprises to provide world-class talent solutions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase