ARx, LLC · 21 hours ago
Mechanical Project Engineer
Glen Rock, PA
Full-time
Onsite
Mid LevelARx, LLC is a company focused on managing and leading equipment projects that support manufacturing operations. The Mechanical Project Engineer will be responsible for specifying, selecting, installing, and validating equipment while ensuring compliance with regulatory requirements and improving mechanical systems.
Health CareManufacturingMedicalPharmaceutical
Hiring Manager
Jamie Lynn Wilson, MBA
Responsibilities
Manage, lead, and execute equipment and mechanical capital projects from concept through handover to operations
Prepare User Requirements Specifications (URS), Functional Specifications (FS), project plans, Scopes of Work (SOW), and Requests for Quote (RFQ) documents
Identify manufacturers, suppliers, integrators and contractors. Obtain and review competitive bids
Submit purchase requisitions and track costs
Perform Design reviews including FMEA
Draft, execute, and document Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
Plan, schedule and coordinate installation, commissioning and qualification activities
Prepare change control documentation, work instructions, equipment installation and operational qualification protocols, and summary reports as required
Ensure safety is designed into equipment per applicable regulations
Ensure long-term maintenance and reliability practices are established
Contribute technical expertise to improve equipment reliability and performance
Provide engineering solutions to address repetitive failures and other problems
Work closely with process owners, Manufacturing, process Engineering, Quality, and Maintenance on continuous improvement initiatives
Support maintenance, production and project management
Support Maintenance with challenging troubleshooting events and root cause analysis
Communicate effectively with AR/ARx associates, suppliers, contractors, and customers
Conduct yourself in a professional, respectful manner consistent with AR/ARx Guiding Principles, and embrace 6S LEAN culture
Perform other related duties as assigned
Qualification
Required
B.S. degree in Mechanical Engineering
Self-starting team player capable of handling multiple, shifting priorities in a regulated environment
Strong problem solving, decision making, and project management skills
Strong analytical skills
Sound organization and communication skills
Ability to work with multiple teams on specification development and project execution
Communicate fluently in English
Tolerate odors and noise associated with manufacturing operations
Travel throughout the manufacturing areas, buildings and campus to allow personal observations of equipment and facilities associated with responsibilities
Travel to customer and vendor facilities as required
Accommodate a flexible work schedule
Machine design experience
Proficiency in computer programs for engineering such as Office 365 applications, AutoCad and Solidworks
Company
ARx, LLC
ARx is a full-service partner for pharmaceutical and biopharma companies.
Founded in 2005
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase