Johnson & Johnson Innovative Medicine · 2 hours ago
Senior Manager, Execution Automation Systems
Spring House, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$122K/yr - $208K/yr
8+ years expJohnson & Johnson Innovative Medicine is dedicated to healthcare innovation, aiming to develop smarter and less invasive treatments. The Senior Manager – CAR-T Execution (Automation) Systems will provide technical expertise in the CAR-T program, ensuring the integration of manufacturing and laboratory systems while collaborating with various teams to drive system delivery and compliance.
Pharmaceuticals
Responsibilities
As CAR-T Execution Systems Owner, represent Engineering in Facility & Systems Design, Qualification and Startup, through transfer to the end user. Support tech transfer activities through process validation and regulatory approval
Author, approve or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, design specifications and operational documents ensuring business requirements are incorporated into the design
Ownership and SME for Execution Systems – secure relationships with systems and technology partners to ensure smooth transition from project to business owner custody. Provide technical support to Engineering/MAM, Design, Automation, IT, Construction Management, CQV/Start-up, Operations, and EHS teams as required during the project phase
In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within systems of responsibility
Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.)
Coordinate the selection and oversight of third-party automation and design services by authoring and initiating formal RFP documentation for driven bidding and selecting automation vendors through execution of objective and data driven analysis documented in bid analysis forms
Support development of the integrated process data map as well as criticality assessments used to define automation and manufacturing systems work
Accountable for cost and resources within system(s) of responsibility
During the facility construction phase, participate and support system testing, C&Q, and turn-over activities
Develop asset management procedures and PMs for execution systems
Accompany all stages of a typical system 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, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
Actively communicate regularly with the Engineering community and develop 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
Required
Minimum of a Bachelor's is required; an advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field
Minimum 8 years of Manufacturing OT and Automation work experience in a Manufacturing Operations and/or Engineering environment
Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry
Experience working with Emerson DeltaV process and batch control systems
Thorough knowledge of ISA S88/S95 standards
Experience with PLC-controlled equipment, process automation hardware and software, robotics, OT networks infrastructure and systems. commissioning/qualification/validation. Experience with Cell Therapy (CAR-T) is an asset
Experience leading 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 handle the workload and as required, be able to lead 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
Proven ability to collaborate internally and externally within a matrix environment
Demonstrated start-up attitude, and 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 optimally, prioritizing and leading multiple tasks simultaneously, and integrating multi-functional issues
Preferred
SME - DeltaV Administrator
Experience with DeltaV Continuous and Batch Configuration
Experience with OT network hardware design and configuration
SME - CSV/GAMP 5/Data Integrity
Experience solving/modeling MBRs using Korber PAS-X
Experience with the setup and programming of various CAR-T processing units
Experience with MiR Fleet Management software/MiR Robots/Staubli End Effectors
Experience with Warehouse ASRS (auto store/auto retrieve) systems automation
Experience with Biosero lab systems and automated lab instrumentation (cell counters and flow cytometers)
Experience programming and solving Python Code
Experience with Allen Bradley PLCs/Siemens PLCs/Beckhoff Industrial PC
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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