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:** 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 Process Validation Engineer II to join our team in Raritan, NJ! **Summary:** The Process Validation Engineer II will support and drive the initiative to maintain a robust and sustainable Process Validation program with strong focus in aseptic process and simulation for the Lentiviral Vector product and CAR-T Drug product through the life cycle of the programs. **Key Responsibilities:** + Prepare well documented protocols and reports for all processes to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practices + Coordinate and support the execution of validation activities with related departments and stakeholders (for example technical groups as Engineering, Manufacturing, Quality Control, Quality Assurance and others as applicable) + Evaluate process/equipment performance during qualification/validation studies in order to determine acceptability, reproducibility, and control. + Support investigations resulting from deviations associated with process validation activities and provides oversight of pre-validation and validation activities resulting from technical changes. + Propose and formalize alternatives for enhancement to qualification and validation processes and procedures in order to support process validation from a lifecycle perspective and ensure the program is sustainable. + Support aseptic process validation from protocol generation, training execution, oversite, and reporting standpoint. + Support equipment performance qualification and ensure consistency with process needs defined by Manufacturing or Tech Support. + Support the Continuous Process Verification (CPV) plan with providing data review/assessment and periodic reports. + Support the establishment of Key Performance Indicators. + Support APQ/APQR site reporting with data analysis and evaluation + Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements. + Provide backup support to the Validation Manager and fellow engineers during absence. + Assist management during internal and external regulatory audits. + Support writing of Quality Risk Assessments for existing and new/changed processes **Qualifications** **Education:** + A minimum of a Bachelors degree in a Scientific or related field is required **Experience and Skills:** **Required:** + A minimum of 2 years of professional relevant business experience + Experience with drafting and driving process validation protocols/reports + GMP manufacturing and/or validation experience in pharmaceutical manufacturing + Familiarity with regulatory guidelines pertaining to process validation + Excellent written and verbal communication skills **Preferred:** + Cell and Gene Therapy experience + CAR-T and/or Lentiviral vector manufacturing experience + Aseptic processing experience + Ability to use various standard programs for data entry and word processing + Ability to learn and operate various enterprise systems including eLIMS, Trackwise, Maximo, EMS, BMS, SAP is highly desirable **Other:** + May require up to 10% domestic 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 :** $63,000 to $102,350 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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 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.