Apply on Employer Site

Johnson & Johnson Innovative Medicine · 18 hours ago

Senior Principal QC Labs Robotics Engineer

Raritan, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

$120K/yr - $207K/yr

8+ years exp

Johnson & Johnson is a leader in healthcare innovation dedicated to improving patient outcomes. They are seeking a Senior Principal QC Labs Robotics Engineer to provide technical expertise in mechatronics systems, ensuring the successful execution of projects related to CAR-T manufacturing processes. The role involves collaboration across various teams to enhance operational efficiency and compliance within the engineering workstream.

Pharmaceuticals

Responsibilities

As CAR-T QC Labs Mechatronics / Robotics System Owner, represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Support tech transfer activities through process validation and regulatory approval

Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents. Ensure business requirements are incorporated into the design; responsible for business owner approval of requirement specifications

Ownership and SME for Mechatronics / Robotics equipment and technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. Provide technical support to Engineering/MAM, Design, Automation, Construction Management, CQV/Start-up, Operations, and EHS teams as required the project

Work with project team to assure robotics deliverables are within project timelines and budget

Coordinate the selection and oversight of third-party engineering and design services through authoring and initiating formal RFP documentation for competitive bidding and then execution of objective and data driven analysis documented in bid analysis forms

In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility

Participate as Mechatronics / Robotics SME and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.)

Assure compliance with relevant safety standards for human and robotics interactions. Provide guidance to team on most current ANSI/RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specifications, and state and federal regulations

Support development of integrated process data map and criticality assessments for use in automation and manufacturing systems deliverables

Accountable for cost and resources within system(s) of responsibility

During the facility construction phase, participate and support system installations, walkdowns, C&Q and turn-over activities

Develop asset management procedures, PM, maintenance and calibration

Drive the standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean/GMP utilities

Accompany all stages of a typical asset lifecycle, including replacement planning & vendor evaluation / selection

Support resolving of technical issues or roadblocks as fast as possible including lessons learned

Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure

Participate in compliance inspections / audits within area of responsibility

Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards

Actively communicate regularly with the Engineering community and foster expertise sharing with CAR-T entities around the globe

Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings

Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)

Develop & maintain robust understanding of aseptic and cell processing techniques

Develop & maintain an in-depth knowledge of cell processing robotics and automation

Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

Qualification

MechatronicsRoboticsAutomationProcess ValidationCAD SoftwareC++PythonMATLABGMP StandardsChange ManagementService MentalityCollaborationProblem SolvingAdaptability

Required

Minimum of a Bachelor's Degree in Mechanical or Electrical Engineering required; focused degree on Mechatronics, Advanced Manufacturing, or Automated Systems preferred

Minimum 8 years of relevant work experience

Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment

Experience with manufacturing and/or laboratory process Automation and Robotics

Proficiency in CAD software, understanding of robotics and automation

Proficiency in programming languages: C++, Python, and/or MATLAB

Familiarity with control systems and associated architecture, signal processing, and PLCs

Experience with equipment / systems commissioning/qualification/validation, Process Automation, IT manufacturing systems

Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry - cell therapy (CAR-T)

Hands-on experience in asset ownership (i.e., equipment, facilities, and utilities)

Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities

In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE)

Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met

Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of Engineering and asset ownership, while identifying areas of improvement

Demonstrated ability to collaborate internally and externally within a matrix environment

Demonstrated start-up mindset, and you proactively search for solutions

You prioritize and provide clear instructions to peers

You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution

You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues