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Johnson & Johnson Innovative Medicine · 21 hours ago

Principal QC Labs Engineer

Titusville, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

$100K/yr - $172K/yr

6+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The Principal QC Labs Engineer will provide technical expertise and oversight for the CAR-T program, ensuring the successful execution of project design, qualification, and transition to operations while collaborating with various teams and partners.

Pharmaceuticals

Responsibilities

As CAR-T Engineering 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 for equipment / technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody

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

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

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, 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

GMP standards knowledgeAsset ownership experienceManufacturing Operations experienceLaboratory Operations experienceProcess AutomationCell therapy knowledgeVendor managementChange controlLeading ChangeLean Manufacturing PrinciplesCritical ThinkingStrategic Thinking

Required

Minimum of a Bachelor's or equivalent University Degree required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field

Minimum 6 years of relevant work experience

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

Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry

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

Preferred

Experience with equipment / systems commissioning/qualification/validation, Laboratory Analytical Instruments, Process Automation, IT manufacturing systems, cell therapy (CAR-T)

Benchmarking

Coaching

Critical Thinking

Facility Management

Leading Change

Lean Manufacturing Principles

Lean Supply Chain Management

Manufacturing Engineering

Manufacturing Flow Management

Organizing

Performance Measurement

Predictive Maintenance