Associate Tech Engineering

BioPharma Consulting JAD Group

About The Position

The Associate Technical Engineer (Automation) provides hands-on automation and technical support for system and equipment optimization, upgrades, replacements, and modifications. This role ensures that all supported areas operate in compliance with corporate policies, industry standards, regulatory requirements, and FDA guidelines. The position supports production, utilities, and maintenance teams by troubleshooting issues, driving process improvements, and maintaining reliable automated operations. KEY RESPONSIBILITIES Evaluate utility systems, process maintenance activities, instrumentation/calibration/electrical systems, and technical cleaning systems to ensure compliance with industry, regulatory, and FDA standards. Assist in the assessment and implementation of engineering improvements, policy changes, compliance enhancements, and optimization initiatives. Provide technical support (TECHSUPPORT) on engineering, compliance, calibration, validation, quality, microbial/environmental, electrical, and process automation issues. Troubleshoot advanced equipment-related issues including mechanical, electrical, pneumatic, and automation failures. Identify and resolve process equipment problems to minimize downtime and ensure operational reliability. Monitor inspection and packaging equipment, investigating and resolving issues in automation, controls, and vision systems. Assist during FDA and other regulatory inspections. Support the preparation and response to inquiries from regulatory agencies. Support preventive and corrective maintenance activities as needed. Maintain accurate operational logs, daily log files, work orders, and documentation according to CFRs, cGMPs, SOPs, and internal policies. Assist with maintaining an up-to-date spare parts inventory system. Develop, revise, and review SOPs, job plans, and work instructions for related areas. Evaluate existing maintenance procedures and support revisions to optimize the maintenance program. Act as a technical resource to the team, providing training and guidance on equipment, maintenance practices, and troubleshooting. Provide professional customer service to internal and external partners, including technical support and issue resolution.

Requirements

Bachelor's degree , OR Associate’s degree + 4 years of directly related experience, OR High school diploma/GED + 6 years of directly related experience.
Leadership and team-building
Strong verbal communication
Technical writing and documentation skills
Organizational and facilitation abilities
Adaptability and change management
Thorough understanding of validation protocol requirements
Equipment-specific technical expertise
Analytical problem solving
Project management, planning, and scheduling
High computer literacy

Nice To Haves

Experience with pneumatics, automatic control systems, and vision inspection systems (e.g., Cognex, Keyence).
Strong troubleshooting skills across mechanical, electrical, and automation disciplines.
Demonstrated ability to reduce equipment downtime through proactive and advanced maintenance techniques.
Experience monitoring and maintaining inspection and packaging equipment.
Ability to recognize, report, and correct equipment malfunctions.
Experience maintaining spare parts inventory systems.
Ability to revise and optimize SOPs, maintenance procedures, and job plans.
Experience providing technical training and support to multidisciplinary teams.
Strong customer service orientation with the ability to communicate complex technical issues clearly.

Responsibilities

Evaluate utility systems, process maintenance activities, instrumentation/calibration/electrical systems, and technical cleaning systems to ensure compliance with industry, regulatory, and FDA standards.
Assist in the assessment and implementation of engineering improvements, policy changes, compliance enhancements, and optimization initiatives.
Provide technical support (TECHSUPPORT) on engineering, compliance, calibration, validation, quality, microbial/environmental, electrical, and process automation issues.
Troubleshoot advanced equipment-related issues including mechanical, electrical, pneumatic, and automation failures.
Identify and resolve process equipment problems to minimize downtime and ensure operational reliability.
Monitor inspection and packaging equipment, investigating and resolving issues in automation, controls, and vision systems.
Assist during FDA and other regulatory inspections.
Support the preparation and response to inquiries from regulatory agencies.
Support preventive and corrective maintenance activities as needed.
Maintain accurate operational logs, daily log files, work orders, and documentation according to CFRs, cGMPs, SOPs, and internal policies.
Assist with maintaining an up-to-date spare parts inventory system.
Develop, revise, and review SOPs, job plans, and work instructions for related areas.
Evaluate existing maintenance procedures and support revisions to optimize the maintenance program.
Act as a technical resource to the team, providing training and guidance on equipment, maintenance practices, and troubleshooting.
Provide professional customer service to internal and external partners, including technical support and issue resolution.