Engineering Technician, 2nd Shift

About the Role

We are seeking an experienced Engineering Technician, 2nd Shift (2:30PM-11:00PM) to support engineering projects from concept through implementation, validation, and project closeout. This role is ideal for a hands-on professional with strong technical expertise, project management capabilities, and experience working in a regulated manufacturing environment.

Key Responsibilities

• Lead and support engineering projects through design, implementation, commissioning, validation, and completion.
• Develop project schedules, plans, and resource requirements.
• Collaborate cross-functionally to ensure successful project execution.
• Support equipment selection, process improvements, automation initiatives, and facility upgrades.
• Participate in installation, qualification, and validation activities (IQ/OQ/PQ).
• Drive continuous improvement efforts focused on productivity, quality, cost reduction, and process optimization.
• Conduct root cause analysis and support CAPA, non-conformance investigations, and corrective actions.
• Maintain engineering documentation including: Specifications, Drawings, Change Controls, Validation Reports.
• Ensure compliance with: cGMP, FDA QMSR, ISO 13485, ISO 14971.
• Provide regular project updates and performance metrics to leadership.
• Support internal and external audits as a technical subject matter expert.

Required Qualifications

• Education: Bachelor's degree in Engineering, Science, or a related technical discipline.
• Experience: 7-10 years of engineering and project experience in a regulated manufacturing, medical device, pharmaceutical, or GMP environment.
• Technical Skills: Strong understanding of engineering design principles. Proficiency with: SolidWorks, AutoCAD. Experience with project planning, technical documentation, and data analysis. Knowledge of: cGMP, FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971.
• Professional Skills: Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities simultaneously. Self-starter with strong organizational skills and attention to detail. Ability to work independently and collaboratively in a fast-paced environment.
• Physical Requirements: Ability to lift up to 40 lbs. Ability to stand, walk, bend, kneel, and perform routine physical activities. Ability to use computers and standard office equipment.

EEO Statement

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.