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 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, Power Point, Teams, Share Point, One Drive).
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
