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 are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Supply Chain EngineeringJob Sub Function: Process EngineeringJob Category:Scientific/TechnologyAll Job Posting Locations:Raritan, New Jersey, United States of AmericaJob Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whoseinsights fuel our science-based advancements. Visionaries like you work on teams thatsave lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to lifewhile championing patients every step of the way. Learn more at are searching for the best talent for a Cell Processing Staff Engineer to join our team.There is a pre-identified candidate for this position, but all candidates will be considered.The Cell Processing Staff Engineer is part of the Cryopreservation team. This role willact as a decision maker in the cryopreservation Team, with responsibilities to develop andown set-up of supply chain technology and processes for a new facility design. You willsupport and implement strategies for change control, risk assessments, andqualification. By collaborating with various other functions (MSAT, R&D, Engineering,quality assurance, quality control, health and safety, information technology,operations, planning, etc.) you will ensure the successful transfer of the cryopreservation process,the timely start of the facility. Theoverall goal is creation of a compliant, reliable, and cost competitive commercial facility.Key Responsibilities:At the beginning of the facility design, this role will require a broad range of knowledgeand will transition to operational readiness and facility startup with ownership ofspecific areas of the Manufacturing process and all related requirements, including thefollowing responsibilities:Provide operational expertise based upon a combination of GMP knowledge offacility design, knowledge in aseptic techniques and process knowledge indevelopment of technology either in ATMPs or equivalent industry that istransferrable to cell and gene therapy products.Provide operational expertise in GMP support processes, for instance, cleaning,environmental monitoring, gowning, waste, GMP documentation needs, etc.Translates input into operational performance efficiencies for user requirementsfor new technology and processes. Ensure completion of user acceptance testingto deliver user requirements and performance efficiencies.Provide operational input to the facility resource model. Leverage the model toshape the development and operability of GMP support processes to deliversolutions for cost competitiveness.Support development and implementation of change control strategy, riskassessment strategy, and qualification strategy to ensure operability and scaleout considerations within the quality and regulatory requirements.Immerse yourself in CAR-T processes, build up solid expertise, ensure timelydevelopment and implementation of a robust operational documentationframework, including operating procedures, work instructions, (electronic) batchrecords etc., and ensure adequate training of the organization.Ensure end-to-end overview of the flow of all material required in your area,including process material, documents, waste, samples.Identify risks and opportunities in relation to process, contamination, cross contamination and mix-up control on the shop floor and drive follow upinitiatives for improvement in close cooperation with operators, QA, QC andoperations management.Act as a lead in root cause related to safety/quality issues in your area.Act as a spokesperson for your area during health care inspections.Support the lean design and implementation of Information Technology systems(SAP, MES, etc) including future releases to continuously improve performanceand compliance.Develop an appropriate governance structure to monitor the operationalperformance of your area at acceptance testing, startup and ongoing.Develop & maintain in depth understanding of the mfg. processes (incl. soundscientific understanding), operational procedures and manufacturingenvironment (Facilities, Utilities, Equipment, Systems, ProcessesDevelop & maintain robust understanding of aseptic and cell processingtechniques.Develop & maintain understanding of relevant regulatory frameworks (generalGMP and specific focus on ATMP) an understanding of biosafety,Qualifications:Education:Minimum of a Bachelor’s or equivalent experience in Engineering, BioscienceEngineering, Industrial Engineering, Pharmacy, Biochemistry or related field.Required:Minimum 4 years of relevant work experience.Experience in one of more of the following areas: cGMP manufacturing,operations technology development, tech transfer, process and equipmentvalidation, and/or quality management.Ability to collaborate internally and externally within a matrix environment.A start-up/can-do attitude and proactively search for solutions.Thrive in a rapidly changing environment and lead as a change agent to promoteflexibility, creativity, and accountability while at the same time handlingprocedures/ guidelines which require strict execution.Work independently and successfully, prioritizing and managing multiple taskssimultaneously, and integrating cross-functional issues.You are able to concisely summarize and present results.PreferredExperience working in a plant manufacturing environment.Experience with equipment/systems commissioning/qualification/validation.deploying new technology into operations, IT/Automation systems, cell therapy(CAR-T) is an asset.OtherThis position supports a dynamic biological manufacturing environment andmay involve working in mechanical spaces and on utility systems or gowning intoGrade B and C environments.Up to 10% domestic/international travel may be requiredJohnson & Johnson is an Equal Opportunity Employer. All qualified applicants willreceive consideration for employment without regard to race, color, religion, sex, sexualorientation, gender identity, age, national origin, disability, protected veteran status orother characteristics protected by federal, state or local law. We actively seek qualifiedcandidates who are protected veterans and individuals with disabilities as defined underVEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive ofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, please contact us via orcontact AskGS to be directed to your accommodation resource.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants willreceive consideration for employment without regard to race, color, religion, sex, sexualorientation, gender identity, age, national origin, disability, protected veteran status orother characteristics protected by federal, state or local law.We actively seek qualified candidates who are protected veterans and individuals withdisabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive ofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to youraccommodation resource.Required Skills:Preferred 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 SelectionThe anticipated base pay range for this position is :94,000 144,500Additional Description for Pay Transparency:Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year 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 Additional information can be found through the link below. Raritan, New Jersey, United States of AmericaType: Full time