Johnson & Johnson Innovative Medicine
Principal QC Labs Engineer
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
2 days ago Be among the first 25 applicants
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 Description
We are searching for a Principal QC Labs Engineer. This Hybrid position can be based in Titusville, New Jersey, Springhouse, Pa, or Raritan, New Jersey. The CAR‑T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. As technical owner of systems, the Engineer is responsible for qualified system turnover to the end user. You will collaborate in the development and own set‑up of supply chain technology and processes for the design of a next‑generation manufacturing facility. Key Responsibilities
Represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Create or support the writing of URSs, Change Controls, Impact Assessments, technical evaluations, and operational documents. Secure relationships with equipment and technology partners to ensure smooth transition from project custody. Engage vendor for factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Support development of integrated process data map and criticality assessments for automation and manufacturing systems deliverables. Accountable for cost and resources within system(s) of responsibility. Participate in system installations, walkdowns, C&Q and turnover activities during construction phase. Develop asset management procedures, preventive maintenance, maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean/GMP utilities. Accompany all stages of a typical asset lifecycle, including replacement planning & vendor evaluation / selection. Support resolving of technical issues or roadblocks quickly, including lessons learned. Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure. Participate in compliance inspections / audits within area of responsibility. Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards. Actively communicate regularly with the Engineering community and foster expertise sharing with CAR‑T entities around the globe. Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings. Qualifications
Minimum 6 years of relevant work experience. Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment. Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry. Hands‑on experience in asset ownership (i.e., equipment, facilities, and utilities). Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities. In‑depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, 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 Engineering and asset ownership, while identifying areas of improvement. Demonstrated ability to collaborate internally and externally within a matrix environment. Demonstrated start‑up mindset, and you proactively search for solutions. You prioritize and provide clear instructions to peers. You 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. You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross‑functional issues. Preferred
Experience with equipment / systems commissioning/qualification/validation, Laboratory Analytical Instruments, Process Automation, IT manufacturing systems, cell therapy (CAR‑T). Other
Requires up to 30% domestic and/or international travel. Salary
The anticipated base pay range for this position is $100,000 to $172,500. 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 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)). This position is eligible to participate in the Company’s long‑term incentive program. 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
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Learn more at https://www.jnj.com Job Description
We are searching for a Principal QC Labs Engineer. This Hybrid position can be based in Titusville, New Jersey, Springhouse, Pa, or Raritan, New Jersey. The CAR‑T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. As technical owner of systems, the Engineer is responsible for qualified system turnover to the end user. You will collaborate in the development and own set‑up of supply chain technology and processes for the design of a next‑generation manufacturing facility. Key Responsibilities
Represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Create or support the writing of URSs, Change Controls, Impact Assessments, technical evaluations, and operational documents. Secure relationships with equipment and technology partners to ensure smooth transition from project custody. Engage vendor for factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Support development of integrated process data map and criticality assessments for automation and manufacturing systems deliverables. Accountable for cost and resources within system(s) of responsibility. Participate in system installations, walkdowns, C&Q and turnover activities during construction phase. Develop asset management procedures, preventive maintenance, maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean/GMP utilities. Accompany all stages of a typical asset lifecycle, including replacement planning & vendor evaluation / selection. Support resolving of technical issues or roadblocks quickly, including lessons learned. Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure. Participate in compliance inspections / audits within area of responsibility. Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards. Actively communicate regularly with the Engineering community and foster expertise sharing with CAR‑T entities around the globe. Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings. Qualifications
Minimum 6 years of relevant work experience. Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment. Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry. Hands‑on experience in asset ownership (i.e., equipment, facilities, and utilities). Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities. In‑depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, 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 Engineering and asset ownership, while identifying areas of improvement. Demonstrated ability to collaborate internally and externally within a matrix environment. Demonstrated start‑up mindset, and you proactively search for solutions. You prioritize and provide clear instructions to peers. You 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. You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross‑functional issues. Preferred
Experience with equipment / systems commissioning/qualification/validation, Laboratory Analytical Instruments, Process Automation, IT manufacturing systems, cell therapy (CAR‑T). Other
Requires up to 30% domestic and/or international travel. Salary
The anticipated base pay range for this position is $100,000 to $172,500. 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 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)). This position is eligible to participate in the Company’s long‑term incentive program. 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
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