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