Experienced Engineer - Cleaning Validation

6014-Janssen Biotech, Inc. Legal Entity; Wilson (NC); Presencial; USD 79.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Vacation hours

Sick time

Holiday pay

Parental Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Descripción de la vacante

Johnson & Johnson is seeking an Experienced Engineer, Process Engineering to join the Manufacturing Science and Technology team in Wilson, NC. The role supports bioprocessing and expansion projects with emphasis on Cleaning Validation and Lifecycle Management.

You will develop technical reports, coordinate MSAT activities with contractors, and ensure compliant execution across QA and manufacturing teams. A strong background in process engineering and regulatory awareness is required.

Formación

• Degree in Life Sciences or Engineering required.
• Excellent verbal and written communication skills.
• Experience in pharmaceutical manufacturing preferred.

Responsabilidades

• Lead MSAT activities in compliance with FDA/EMEA and company procedures.
• Primary focus in Cleaning Validation and related development tasks.
• Develop MSAT documentation and coordinate reviews/approvals.
• Support Manufacturing with routine operations and projects as needed.
• Track issues, nonconformances, and prioritize MSAT activities.

Conocimientos

Analytical Reasoning

Gemba Kaizen

Process Engineering

Problem Solving

Technical Research

STEM Application

Lean Supply Chain

Validation Testing

Educación

Life Sciences/Engineering degree

Descripción del empleo

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.com As 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 Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Wilson, North Carolina, United States of America

Job Description: Johnson & Johnson is currently seeking a Experienced Engineer, Process Engineering to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strongportfolio growth and continue delivering breakthrough innovation and transformational medicinesfor patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. 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

Job Summary: Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bioprocessing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.

Essential Job Duties and Responsibilities:

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements.
• Primary activities are in the Cleaning Validation area.
• Performing cleaning Cycle Development, Performance Qualifications, Clean Hold Studies, and Re-Qualification executions.
• Develop MSAT documentation (e.g. protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / the project schedule.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of a Senior MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.

Minimum Qualification:

Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required. Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. Excellent computer proficiency e.g MS Office, Excel, SAP. At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent. Must be able to work independently with minimum supervision to meet tight deadlines.

Other Requirements:

• Experience in biological Cleaning Validation (Minimum 2 years).
• Also, beneficial would be experience in Projects, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Thermal Validation, supporting process improvement projects, Supporting New product Introduction/ process validation.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
• Ability to lead multi-functional team and to manage complexity and change.
• Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities.

Required Skills: Preferred Skills:

Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing

The anticipated base pay range for this position is : 79,000-120,000

Additional Description for Pay Transparency:

• Vacation –120 hours per calendar year
• 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.