Engineering Technical Specialist
vector biomedGaithersburg, MD
$85k - 115k per year
APPLYEngineering Technical Specialist
vector biomedGaithersburg, MDSenior L5
$85k - 115k per year
Pharmaceutical Preparation ManufacturingEngineering ServicesOther Scientific and Technical Consulting Services
APPLY NOWSummary:
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 packageso Where applicable, manage and provide oversight on vendor qualification support.
- Metrology (25%)o Coordinate with system owners to ensure schedule adherenceo Provide oversight on vendor calibration/certification activitieso Review and approve calibration/certification reportso Address relevant out-of-calibration and/or excursionso 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 orderso 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/systemso 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 validationo Metrologyo Facilities maintenanceo 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
Matching similar jobs
Level
Senior L5
Salary
$85k - 115k per year
Location
Gaithersburg, MD
Occupation
Validation Engineers
Industry
Pharmaceutical Preparation Manufacturing
Posted
9 days ago