Engineering Technical Specialist

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.

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Key Responsibilities:

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• Validation/Revalidation (25%)

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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)

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o Execute protocols, address deviations/non-conformance, and develop final reports for executed protocols.

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o Coordinate with key stakeholders on scheduling logistics, execution and documentation closure.

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o Review/approve protocols, reports and validation summary packages

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o Where applicable, manage and provide oversight on vendor qualification support.

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• Metrology (25%)

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o Coordinate with system owners to ensure schedule adherence

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o Provide oversight on vendor calibration/certification activities

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o Review and approve calibration/certification reports

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o Address relevant out-of-calibration and/or excursions

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o Where applicable, perform simple calibration that includes but not limited to temperature, pressure and relative humidity.

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• Facilities Maintenance (25%)

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o Develop, execute and address work orders (corrective and preventive)

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o Provide oversight, review and approve vendor/contractor service work orders

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o Respond to building/equipment alarms as needed

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• Electronic Quality Maintenance System (eQMS Maintenance) (25%)

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o Provide technical support to develop and maintain equipment/system life cycle.

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o Work cross-functionally to onboard and offboard equipment/systems

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o Assess and evaluate opportunities to enhance equipment/system life cycle.

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Basic Qualifications

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• Education: Bachelor’s degree in science or relevant discipline preferred but professional experience in appropriate role may substitute.

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• Experience: 3+ years of recent experience in one or more of the following areas:

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o Equipment validation

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o Metrology

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o Facilities maintenance

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o Electronic Maintenance System

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• Skills:

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• Good understanding cGMP’s, regulatory requirements, and quality systems.

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• Strong written and verbal communication

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• Good troubleshooting, problem-solving skills and attention to detail.

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• Sound knowledge in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).

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Salary Range: $85k - 115k per year

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Physical Requirements

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• Ability to move 50 lbs.

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• Ability to climb ladders and stairs

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• Must be able to perform repetitive motion activities during working hours

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• Occasional off-hours and weekends as needed.

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• Ability to use basic tools with proficiency