Senior Cryopreservation Process Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs for humanity.

About the role

We are searching for a Cell Processing Staff Engineer to join our Cryopreservation team. This role will act as a decision maker in the cryopreservation team, developing and owning the setup of supply chain technology and processes for a new facility design. You will support and implement strategies for change control, risk assessments, and qualification, collaborating with various functions (MSAT, R&D, Engineering, Quality Assurance, Quality Control, Health and Safety, Information Technology, Operations, Planning) to ensure the successful transfer of the cryopreservation process and the timely start of the facility. The goal is to create a compliant, reliable, and cost-competitive commercial facility.

This position supports a dynamic biological manufacturing environment and may involve working in mechanical spaces, utility systems, or gowning into Grade B and C environments. Up to 10% domestic/international travel may be required.

Responsibilities

• Provide operational expertise based on GMP knowledge of facility design, aseptic techniques, and process knowledge in ATMPs or equivalent industries transferable to cell and gene therapy products.
• Offer operational expertise in GMP support processes, including cleaning, environmental monitoring, gowning, waste management, and GMP documentation needs.
• Translate input into operational performance efficiencies for user requirements for new technology and processes.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Provide operational input to the facility resource model and leverage it to shape the development and operability of GMP support processes for cost competitiveness.
• Support development and implementation of change control, risk assessment, and qualification strategies to ensure operability and scale-out considerations within quality and regulatory requirements.
• Immerse yourself in CAR-T processes, build expertise, and ensure timely development and implementation of a robust operational documentation framework (e.g., operating procedures, work instructions, electronic batch records).
• Ensure adequate training of the organization.
• Maintain an end-to-end overview of material flow in your area, including process material, documents, waste, and samples.
• Identify risks and opportunities related to process, contamination, cross-contamination, and mix-up control on the shop floor; drive follow-up initiatives for improvement in cooperation with operators, QA, QC, and operations management.
• Act as a lead in root cause analysis for safety/quality issues in your area.
• Serve as a spokesperson for your area during healthcare inspections.
• Support the lean design and implementation of Information Technology systems (e.g., SAP, MES) and future releases to improve performance and compliance.
• Develop an appropriate governance structure to monitor operational performance during acceptance testing, startup, and ongoing operations.
• Develop and maintain an in-depth understanding of manufacturing processes (including scientific principles), operational procedures, and the manufacturing environment (facilities, utilities, equipment, systems, processes).
• Develop and maintain a robust understanding of aseptic and cell processing techniques.
• Develop and maintain an understanding of relevant regulatory frameworks (general GMP and ATMP-specific) and biosafety.

Requirements

• Minimum of a Bachelor’s degree or equivalent experience in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or a related field.
• Minimum of 4 years of relevant work experience in one or more of the following areas: cGMP manufacturing, operations technology development, tech transfer, process and equipment validation, and/or quality management.
• Ability to collaborate internally and externally within a matrix environment.
• Startup mindset with a proactive approach to problem-solving.
• Ability to thrive in a rapidly changing environment and lead as a change agent while adhering to procedures requiring strict execution.
• Work independently, prioritize and manage multiple tasks simultaneously, and integrate cross-functional issues.
• Concisely summarize and present results.

Preferred Qualifications

• Experience working in a plant manufacturing environment.
• Experience with equipment/systems commissioning, qualification, and validation.
• Experience deploying new technology into operations or with IT/Automation systems.
• Experience in cell therapy (CAR-T) is an asset.

Skills

• Agile Decision Making
• Coaching
• Corrective and Preventive Action (CAPA)
• Critical Thinking
• Emerging Technologies
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Product Costing
• Product Improvements
• Science, Technology, Engineering, and Math (STEM) Application
• Situational Awareness
• Technical Research
• Technologically Savvy
• Validation Testing
• Vendor Selection

Pay

The anticipated base pay range for this position is $94,000 – $144,500.

Benefits

• Sick time: 40 hours per calendar year (56 hours for employees in Washington State).
• Holiday pay, including Floating Holidays: 13 days per calendar year.
• Work, Personal, and Family Time: up to 40 hours per calendar year.
• Parental Leave: 480 hours within one year of the birth/adoption/foster care of a child.
• Condolence Leave: 30 days for an immediate family member; 5 days for an extended family member.
• Caregiver Leave: 10 days.
• Volunteer Leave: 4 days.
• Military Spouse Time-Off: 80 hours.