Building & Equipment Engineer I

BioSpace; Raritan (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

A biotechnology company in Raritan, NJ is seeking a Building & Equipment Engineer I role within their Facilities & Engineering team. This position focuses on providing engineering support for computerized systems and managing projects in a cGMP environment. The ideal candidate should have a bachelor's degree in a relevant field and a minimum of 4 years of relevant experience, particularly in aseptic manufacturing. Strong communication skills and a detail-oriented mindset are essential for this role.

Qualifications

• A minimum of 4 years relevant work experience is required with expertise in 21 CFR Part 11, 58, 210 and 211.
• Experience working in an aseptic manufacturing facility, preferably cell therapy.
• Strong interpersonal and written/oral communication skills.
• Aseptic manufacturing facility experience preferred (cell therapy)
• Strong GMP data integrity knowledge and cGMP practices

Responsibilities

• Provide engineering support for building and equipment computerized systems.
• Manage vendor and data management within the plant's computerized systems.
• Handle training for end users and execute against SOPs.
• Author, review and execute documentation including master and completed protocols
• Coordinate with cross functional teams and inspections to ensure compliance

Skills

GMP compliance knowledge

Interpersonal communication skills

Project management

Attention to detail

Project management

Communication skills

Team collaboration

Data integrity

Change control

Education

Bachelor’s Degree in Science, Engineering, Automation, Information Technology or equivalent

Tools

SOPs

BAS

EMS

Manufacturing automation software

Job description

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Building & Equipment Engineer I as part of the Facilities & Engineering team based in Raritan, NJ.

Role Overview

This position will be responsible for providing engineering support to implement and maintain building and equipment computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day‑to‑day activities inclusive of project execution and management, vendor management, data management, life‑cycle management, issues, deviations, corrections, remediation and improvement efforts of computerized 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

• Acts as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others.
• Works with above plant functions to successfully implement and maintain tools, standards, policies and procedures in compliance.
• Handling day‑to‑day activities inclusive of project execution and management, vendor management, data management, life‑cycle management, issues, deviations, corrections, remediation and improvement efforts within the plant of all computerized systems such as manufacturing and laboratory equipment automation, EMS, BAS, and other software, systems and associated interfaces.
• Conducts local system data performance monitoring of 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.
• Manages multiple and complex projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Acts as an SME for internal and external agency inspections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering, Automation, Information Technology or equivalent technical discipline is required.
• A minimum of 4 years relevant work experience is required with expertise in 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines. It is preferable that the candidate have 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