Engineering Technician

#Eng-IT-01
Engineering Technician 2nd Shift
Location: Branchburg, NJ
Status: Full-time direct hire
Compensation: $80,000 to $100,000 per year
Experience: GMP environment highly preferred
 
SUMMARY:
The Engineering Technician is responsible for independent technical task assignments and executing engineering projects to completion. This role ensures the Technician's tasks are delivered on time, within scope, and within budget while meeting all technical, quality, regulatory, and safety requirements. This is 2^nd shift from 2:30pm to 11pm

The Engineering Technician provides technical feedback to the Engineering Manager, drives cross-functional collaboration, and supports continuous improvement initiatives. This position requires strong expertise in engineering design, problem solving, and data-driven decision making within a regulated manufacturing or GMP environment.

The role demands a proactive self-starter who is highly organized, detail oriented, and capable of managing multiple priorities in a fast-paced environment. The Engineering Technician will demonstrate professionalism, effective communication skills, technical competencies, and the ability to adapt to evolving business needs.

PRIMARY FUNCTIONS

1. Maintain a technical focus on engineering projects from initiation through design, implementation, validation, and closeout.
2. Develop project plans, schedules, and resource requirements.
3. Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, Supply Chain, and Operations.
4. Ensure engineering solutions meet applicable regulatory requirements, quality standards, and company procedures.
5. Provide technical expertise for equipment selection, process design, automation, and facility improvements.
6. Engage with installation, commissioning, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes.
7. Identify project risks and implement mitigation strategies to ensure successful execution.
8. Drive continuous improvement initiatives focused on productivity, cost reduction, and process optimization.
9. Support root cause investigations, non-conformance resolution, and corrective and preventive actions (CAPA).
10. Oversee engineering documentation including specifications, drawings, change controls, and validation reports.
11. Monitor project performance metrics and provide regular status updates to leadership.

1. Ensure compliance with cGMP, FDA QMSR, ISO 13485, and ISO 14971 risk management requirements.
2. Participate in internal and external audits as technical subject matter expert.
3. Achieve established project milestones and performance goals.
4. Adhere to all safety rules, quality standards, and company policies and procedures.
5. Perform additional responsibilities as assigned to support departmental and organizational objectives.

KNOWLEDGE, SKILLS & QUALIFICATIONS

1. Minimum of 7–10 years of engineering and project experience in a regulated manufacturing or GMP environment.
2. Strong knowledge of engineering design principles and a good working knowledge of Solid Works and ACAD.
3. Working knowledge of cGMP, quality systems, and applicable regulatory standards
4. Extensive working knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 requirements.
5. Proficiency in project planning tools, data analysis and technical documentation
6. High level of professionalism with excellent interpersonal and customer service skills.
7. Exceptional time management abilities with proven success managing multiple priorities simultaneously.
8. Outstanding verbal and written communication skills.
9. Demonstrated ability to take ownership and drive tasks to completion.
10. Demonstrated ability to work independently, collaborate effectively in a team, and drive projects to completion.
11. Ability to work in a fast-paced environment with the flexibility to adjust to and adapt to shifting priorities.
12. Strong analytical and problem-solving skills with sound decision making capabilities.
13. Dependable, punctual and committed to maintain a positive attitude and strong work ethic.
14. Must be authorized to work in the United States.