Sr. Principal Engineer, Equipment Preparation Lead
Wilson, North Carolina, United States · On-site
Senior+
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 in…
Skills: Process Engineering, Capital Project Execution, Equipment Preparation, Autoclaves, Parts Washers
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 in…
Skills: Process engineering, Packaging equipment, Capital project execution, Biotherapeutic manufacturing, Aseptic processing
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 in…
Skills: Aseptic processing, Biotherapeutic drug product compounding, Single-use technology, Process engineering, Capital project execution
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 in…
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Skills: Electrical Engineering, Instrumentation, Process Engineering, Project Management, Medium Voltage Systems
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Skills: Logistics process engineering, Capital project execution, Biotherapeutic cGMP, Warehouse design, Material handling equipment
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Skills: Sustainability Management, ESG Principles, Market Access, Health Economics, Data Analysis
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 in…
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 in…
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 in…
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Responsable (H/F) de développement des ventes spécialiste de l' optique Paris Intramuros et Corse
Issy-les-Moulineaux, Ile-de-France, France · On-site
$35k–$56k/yr
Mid level
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 in…
Skills: Account Management, Collaboration, Communication, Cultural Competence, Customer Centricity
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Skills: Executive support, Administrative duties, Scheduling, Microsoft Excel, Microsoft PowerPoint
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 in…
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Skills: Medical Device Sales, Pharmaceutical Sales
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Skills: Regulatory Affairs, Quality Assurance, Process Management, Supply Chain Management
Hopewell Township, New Jersey, United States · Hybrid
$102k–$173k/yr
Senior
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 in…
Skills: Supply chain management, Performance management, Data analytics, Business intelligence, Operational excellence
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 in…
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Skills: ERP Platform Support, Supply Chain Management, Business Transformation, SAP S/4 HANA, Project Delivery
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 in…
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Full-time
bachelor degree, postgraduate degree
Posted 13d ago
Apply by Aug 31
~40 hrs/week
Responsibilities
The Sr. Principal Engineer will serve as the subject matter expert for equipment preparation systems in a new cGMP drug product manufacturing plant. They are responsible for leading the design, commissioning, qualification, and start-up of equipment while ensuring compliance with regulatory standards.
Requirements
Candidates must possess a minimum of 10 years of experience in process engineering or capital project execution within the biotherapeutic or aseptic manufacturing industry. A Bachelor's degree in engineering is required, with a preference for an MS or MBA.
Full job description
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 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:
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.
Apply today for this exciting opportunity to be part of our growing team!
As part of the Global Process Engineering team, the Sr. Principal Engineer, Equipment Preparation Lead, is the technical, subject matter (SME) expert in the equipment preparation area (parts prep, autoclaves, parts washers, COP/SOP, filter integrity testing). They will be accountable for overall E2E process engineering leadership in the design and execution of the equipment preparation area for a new cGMP drug product manufacturing plant. They will be responsible for leveraging their scientific, technical, and business expertise to develop the system equipment, solve sophisticated technical issues, optimize the process, lead commissioning and qualification activities and line start-up and ensure full compliance to regulatory standards.
Key Responsibilities:
Development and delivery of the equipment preparation area system specifications, and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs)
Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
Lead the detailed design and development of the equipment preparation area collaborating with a diverse multi-functional team including strategic equipment vendors
Lead equipment FAT, SAT, C&Q, and start-up
Technical issue resolution on the system during C&Q testing and the readiness of the system to start C&Q activities
Helping to identify and expedite key activities across multiple business functions (Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS (Engineering & Property Services), and EHS
Ensure alignment across evolving business needs and require strong partner management and leadership skills to collaborate across these multiple business partners.
Maintain a solid understanding of industry trends and benchmarking against internal/external practices
Apply data-driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance.
Ensure compliance with policies, procedures, government regulations, and customer specifications
Qualifications
Education:
Minimum of a Bachelor's Degree in engineering required; MS or MBA preferred.
Experience and Skills:
Required:
A minimum of 10 years experience in process engineering or capital project execution of equipment preparation equipment – autoclaves, parts washers, filter integrity testing, COP (clean-out-of-place), SOP (steam-out-of-place), equipment disassembly and assembly.
Track record of developing and maintaining strong partnerships with key stakeholders
Ability to lead and motivate multicultural teams and remote customers
Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as filling system SME
Excellent problem-solving skills when handling potential conflicts
cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
EHS requirements, with particular focus on EHS by design and construction safety
Start-up processes and Commissioning & Qualification of equipment preparation equipment (autoclaves, parts washers, filter integrity test stations, COP/SOP stations)
Principles for engineering design for drug products in the Biotherapeutic industry
Construction & Procurement process
Project Controls processes
Project scheduling
Strong technical process engineering knowledge and experience and has a great passion for solving highly complex technical problems
Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape
Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team
Preferred:
Consistent track record on leading capital projects for aseptic processing equipment including autoclaves, parts washers, filter integrity units, and COP/SOP systems
Capital project leadership of aseptic manufacturing equipment, green or brown field GMP manufacturing facility start-up, in the range of $100 - $500 MM
Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment in filling systems
Experience in green or brown field GMP manufacturing facility start-up
Other:
This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
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.
Required Skills:
Preferred Skills:
Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Health CareBiotechnologyMedicalManufacturingPharmaceutical
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Health CareBiotechnologyMedicalManufacturingPharmaceutical