Full Job Description
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose
insights fuel our science-based advancements. Visionaries like you work on teams that
save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life
while championing patients every step of the way. Learn more at
https://www.jnj.com/innovative-medicine
We 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 will
act as a decision maker in the cryopreservation Team, with responsibilities to develop and
own set-up of supply chain technology and processes for a new facility design. You will
support and implement strategies for change control, risk assessments, and
qualification. 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. The
overall 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 knowledge
and will transition to operational readiness and facility startup with ownership of
specific areas of the Manufacturing process and all related requirements, including the
following responsibilities:
Provide operational expertise based upon a combination of GMP knowledge of
facility design, knowledge in aseptic techniques and process knowledge in
development of technology either in ATMPs or equivalent industry that is
transferrable 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 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. Leverage the model to
shape the development and operability of GMP support processes to deliver
solutions for cost competitiveness.
Support development and implementation of change control strategy, risk
assessment strategy, and qualification strategy to ensure operability and scale
out considerations within the quality and regulatory requirements.
Immerse yourself in CAR-T processes, build up solid expertise, ensure timely
development and implementation of a robust operational documentation
framework, including operating procedures, work instructions, (electronic) batch
records 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 up
initiatives for improvement in close cooperation with operators, QA, QC and
operations 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 performance
and compliance.
Develop an appropriate governance structure to monitor the operational
performance of your area at acceptance testing, startup and ongoing.
Develop & maintain in depth understanding of the mfg. processes (incl. 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 understanding of relevant regulatory frameworks (general
GMP and specific focus on ATMP) an understanding of biosafety,
Qualifications:
Education:
Minimum of a Bachelor's or equivalent experience in Engineering, Bioscience
Engineering, 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 equipment
validation, 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 promote
flexibility, creativity, and accountability while at the same time handling
procedures/ guidelines which require strict execution.
Work independently and successfully, prioritizing and managing multiple tasks
simultaneously, and integrating cross-functional issues.
You are able to concisely summarize and present results.
Preferred
Experience 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.
Other
This position supports a dynamic biological manufacturing environment and
may involve working in mechanical spaces and on utility systems or gowning into
Grade B and C environments.
Up to 10% domestic/international travel may be required
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 Selection
The anticipated base pay range for this position is :
94,000 144,500
Additional 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. https://www.careers.jnj.com/employee-benefits
