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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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality 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 Sr. Engineer – Commissioning Qualification Validation (CQV) to join our Team !

Are you interested in joining a team that passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today. To support the global CAR-T program, Janssen is rapidly growing its manufacturing and laboratory capabilities. This position offers a perfect environment to understand CAR-T Cell Processing Manufacturing Operations and the underlying Supply Chain systems (Planning, Quality, Distribution, EHS, etc.), something unique given the limited amount of Cell Therapy manufacturers worldwide. Apply today!

The CQV Senior Engineer is responsible for performing and handling commissioning and qualification (C&Q) activities related to equipment, systems, and processes in a regulated environment. They ensure compliance with Janssen, as well as industry standards and regulations, and develop and execute C&Q protocols, and provide technical support. In addition, they will create and sustain continuous procedural improvements to boost efficiency of C&Q activities. The Senior Engineer works collaboratively with cross-functional teams to deliver projects on time, troubleshoots issues, and provides recommendations for improvements. This position will be supporting both Lentiviral vector Manufacturing site and CAR-T site within Raritan Manufacturing Facility.

Key Responsibilities:

• Prepare, generate, and flawlessly execute C&Q lifecycle documents (e.g., Project Plan, IQ /OQ / PQ protocols, Traceability Matrix, Summary Reports, 21 CFR Part 11 Assessment, etc.) for a variety of utility, facility, process, and laboratory equipment.

• Write and execute the Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities.

• Support creation of Change Controls and User Requirement Specification, as well as FMEA as needed.

• Drive investigations, deviations, and corrective and preventive actions towards successful and compliant closure as it relates to equipment qualified state performance.

• Follow all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WIs, Company policies, and corporate standards.

• Maintain partnerships with contractors and vendors that handle C&Q and Re-qualification activities.

Qualifications

Education:

• Minimum of a Bachelor’s/University or equivalent University Degree required; focused degree in Engineering, Science, or related field preferred

Experience and Skills:

Required:

• Minimum 3 years of relevant work experience

• Demonstrated experience with equipment validation within the pharmaceutical industry

• Hands-on experience with FAT, SAT, IQ, OQ, and/or PQ documentation generation and execution on automated systems

• Validation experience in the areas of equipment, utilities, and/or facility

• In-depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, FAGG/FAMHP, 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 asset ownership, while identifying areas of improvement

• Strong problem-solving, attention to detail, and excellent written and verbal communication skills, including the ability to write procedures for a technical environment, documenting complex technical solutions, and communicating effectively with internal and external partners

Preferred:

• Experience with Computer System Validation, and Automation

• Experience with Trackwise / Comet, Kneat, SAP, and/or truVault system

• Experience within Manufacturing (GxP) environment

• Experience working in a large, highly-matrixed environment

Other:

• Located in Raritan, New Jersey, this position requires to work on-site

• Requires up to 10% domestic and/or international travel

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 ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

USD $77,000 to $124,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.