HVAC Automation & Controls Technician

Legend Biotech • Raritan, NJ

84d

About The Position

Legend Biotech is seeking HVAC Automation & Controls Technician as part of the Facilities & Engineering team based in Raritan, NJ. 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 in 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.

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.
• Deep knowledge of Honeywell and Siemens BAS software, hardware, protocols and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet, MODBUS, APOGEE P2).
• Experience 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).

Responsibilities

• Works with above plant functions to successfully implement and maintain tools, standards, policies and procedures in compliance.
• Handling 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.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options available to employees in eligible roles.
• Eight weeks of paid parental leave after just three months of employment.
• Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Legal assistance.
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Commuter benefits.
• Family planning and care resources.
• Well-being initiatives.
• Peer-to-peer recognition programs.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees