Senior Manager, Execution Automation Systems
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $122,000 - $208,250 per year
Job Level
About the role
- 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.).
- Support developing the integrated process data map as well as criticality assessments used to define automation and manufacturing systems work.
Requirements
- Minimum of a Bachelor’s is required; advanced 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.
- Experience with Cell Therapy (CAR-T) is an asset.
- 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).
- Proven ability to collaborate internally and externally within a matrix environment.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process validationregulatory approvalUser Requirement SpecificationsChange ControlsImpact Assessmentsdesign specificationsautomation systemsEmerson DeltaVPLC-controlled equipmentGMP standards
Soft Skills
collaborationtechnical supportdecision makingrelationship management