Associate Engineer

Calsoft Labs

New Albany, OH

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JOB DETAILS

SKILLS

Architectural Services, Automation, Calibration, Communication Skills, Current Good Manufacturing Practice (cGMP), Electrical Engineering, Electricity, Equipment Maintenance/Repair, Equipment Validation, FDA Requirements, GMP (Good Manufacturing Practices), HVAC, Human Machine Interface (HMI), Identify Issues, Industry Standards, Instrumentation, Ladder Logic, Maintain Compliance, Maintenance - Electrical, Manufacturing, Mentoring, Operational Support, Plumbing, Problem Solving Skills, Programmable Logic Controller (PLC), Regulations, Regulatory Compliance, Standard Operating Procedures (SOP), Systems Engineering, Team Player, Technical Support

LOCATION

New Albany, OH

POSTED

30+ days ago

Note:
Fully onsite New Albany, OH
Shift details: PM shift 6:00 pm 6:30 am, 2-2-3 schedule.

Ideal candidate is an Automation Technician (2 years) with strong hands-on PLC troubleshooting skills, ladder logic reading, HMI familiarity, and packaging equipment experience. Able to collaborate with mechanical techs, and adept at diagnosing electrical/automation issues in a GMP manufacturing environment. Industry background is flexible; key requirement is practical automation experience. Strong communication and problem-solving skills are essential.

In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.

Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and Client policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.

About the Company

Calsoft Labs

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