Summary: The Associate Technical Engineer will support automation and optimization strategies for various systems and equipment, ensuring compliance with corporate policies, FDA standards, and industry regulations.
This role requires a proactive approach to system maintenance, technical support, and compliance management, with an emphasis on regulatory preparedness and process improvements.
Key Responsibilities: Evaluate utility systems, process maintenance, instrumentation/calibration, and technical cleaning systems to ensure compliance with industry and FDA standards.
Collaborate with TECHSUPPORT to address engineering, regulatory, calibration, compliance, validation, and process automation issues.
Provide support during FDA and other regulatory inspections, responding to inquiries and ensuring adherence to standards.
Assist in implementing engineering improvements, policy changes, and optimization programs.
Core Competencies: Strong teamwork and leadership abilities.
Thorough understanding of equipment and validation protocol requirements.
Proven skill in identifying and resolving technical issues.
Experience in scheduling and managing technical projects.
Effective verbal and written communication skills, including technical writing.
Ability to manage change and work in a fast-paced environment.
Proficiency in relevant software tools for technical documentation and scheduling.
Requirements Qualifications: Bachelor's degree in a related field; OR Associate degree with a minimum of 4 years of directly related experience; OR High school diploma/GED with at least 6 years of directly related experience.
Preferred Skills & Experience: Proficiency in packaging equipment, including Thermoformer, Cartoner, Case Packer, Labeler, and assembly equipment.
Knowledge of Vision Systems, Serialization, Sensors, and Cobots.
Experience with mechanical adjustments, motor replacements, VFDs, and pneumatic and electrical/mechanical troubleshooting.
Familiarity with PLC backup, preventive maintenance, and training tools.
Shift: 12-hour shift, rotating schedule (5:00 AM – 5:30 PM or 5:00 PM – 5:30 AM)