HVAC Automation & Controls Technician (Contract)

Legend Biotech USA; Raritan (NJ); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a dedicated HVAC Automation & Controls Technician to join their Technical Operations team. This exciting role involves providing engineering support for building automation systems in a cutting-edge manufacturing facility. The successful candidate will manage daily activities, ensuring compliance with cGMP requirements while collaborating with cross-functional teams. If you're passionate about automation and thrive in a dynamic environment, this position offers a unique opportunity to contribute to innovative cell therapy production and make a real impact on patient care.

Qualifications

• 2+ years as an automation and controls field service technician required.
• Deep knowledge of Honeywell and Siemens BAS systems is preferable.

Responsibilities

• Provide engineering support for building automation and controls systems.
• Handle daily activities for BAS, EMS, and automation systems.

Skills

Troubleshooting complex systems

GMP compliance knowledge

Interpersonal communication skills

Process excellence tools

Attention to detail

Education

Bachelor's Degree in Science, Engineering, Automation, or IT

Tools

Honeywell BAS software

Siemens BAS software

BAS

EMS

TrackWise

CMMS

Maximo

Microsoft Office

Job description

Legend Biotech is seeking a HVAC Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible for handling day-to-day activities inclusive of life cycle management, issues, deviations, corrections, remediation, and improvement efforts of automation and controls systems for facility, equipment, systems, and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require systems engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination, and collaboration across relevant cross-functional groups to establish a strong, compliant program to enable robust production, testing, and release of product to patients.

Key Responsibilities

• Works with above plant functions to successfully implement and maintain tools, standards, policies, and procedures in compliance.
• Handles day-to-day activities for BAS, EMS, and other automation and controls system software, hardware, and associated interfaces inclusive of data management, issues, deviations, corrections, remediation, and improvement.
• Conducts local system data performance monitoring and analysis for BAS and EMS.
• Executes against SOPs, inclusive of data backup, disaster recovery, user administration, etc.
• Implements and maintains network configuration for BAS, EMS, and facility automation equipment.
• Provides training to end users.
• Provides user-defined reports and facilitates ad-hoc queries.
• Provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering, Automation, Information Technology or equivalent technical discipline is required.
• A minimum of 2 years as an automation and controls field service technician. Experience troubleshooting complex systems is a must. It is preferable that the candidate have deep knowledge of Honeywell and Siemens BAS software, hardware, protocols, and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet, MODBUS, APOGEE P2). Working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Thorough knowledge and understanding of GMP data integrity standards.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols.
• Experience with BAS, EMS, TrackWise, CMMS, and Maximo.
• Familiarity with IT application design and deployment.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Language: English.