Summary: The Engineering Technical Specialist will provide direct/indirect technical support for GMP and Non-GMP operations (Process Development, Clinical, and Manufacturing operations). The role encompasses validation, metrology and facilities maintenance for various equipment/systems. The candidate performs quality functions to ensure that equipment/systems and quality procedures adhere to system requirements and can perform properly and consistently.
Key Responsibilities:
• Validation/Revalidation (25%)
o Develop documentation related to validation/re-validation. These include but are not limited to User Requirements, Risk Assessments, Installation, Operation and Performance protocol (IOPQ)
o Execute protocols, address deviations/non-conformance, and develop final reports for executed protocols.
o Coordinate with key stakeholders on scheduling logistics, execution and documentation closure.
o Review/approve protocols, reports and validation summary packages
o Where applicable, manage and provide oversight on vendor qualification support.
• Metrology (25%)
o Coordinate with system owners to ensure schedule adherence
o Provide oversight on vendor calibration/certification activities
o Review and approve calibration/certification reports
o Address relevant out-of-calibration and/or excursions
o Where applicable, perform simple calibration that includes but not limited to temperature, pressure and relative humidity.
• Facilities Maintenance (25%)
o Develop, execute and address work orders (corrective and preventive)
o Provide oversight, review and approve vendor/contractor service work orders
o Respond to building/equipment alarms as needed
• Electronic Quality Maintenance System (eQMS Maintenance) (25%)
o Provide technical support to develop and maintain equipment/system life cycle.
o Work cross-functionally to onboard and offboard equipment/systems
o Assess and evaluate opportunities to enhance equipment/system life cycle.
Basic Qualifications
• Education: Bachelor’s degree in science or relevant discipline preferred but professional experience in appropriate role may substitute.
• Experience: 3+ years of recent experience in one or more of the following areas:
o Equipment validation
o Metrology
o Facilities maintenance
o Electronic Maintenance System
• Skills:
• Good understanding cGMP’s, regulatory requirements, and quality systems.
• Strong written and verbal communication
• Good troubleshooting, problem-solving skills and attention to detail.
• Sound knowledge in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).
Salary Range: $85k - 115k per year
Physical Requirements
• Ability to move 50 lbs.
• Ability to climb ladders and stairs
• Must be able to perform repetitive motion activities during working hours
• Occasional off-hours and weekends as needed.
• Ability to use basic tools with proficiency
Engineering Technical Specialist in Gaithersburg at Vector BioMed, Inc.
This position is listed as contract and onsite. It was posted 2 days ago.