Principal Engineer

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 ;br>
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 ;/b>

We are searching for the best talent for a Principal Engineer to join our team.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT), the MSAT Large Molecule Drug Substance team is responsible for the technology transfer, qualification, lifecycle management and optimization of Drug Substance clinical and commercial manufacturing processes at both internal and external manufacturing sites. The role requires extensive drug substance process knowledge, project management skills and familiarity with the latest digital and innovative technologies in the industry. The successful candidate will join a global team in developing and optimizing a world class supply chain to support the Innovative Medicines Large Molecule product portfolio.

Summary:

Principal Engineer works collaboratively with other functional areas and management to drive decisions regarding process design, equipment selection, operating modes, method transfers, validation and regulatory strategy to ensure successful technology transfers with optimized efficient processes that meet business needs in terms of supply, quality, regulatory compliance, flexibility and cost effectiveness. Addresses process non-conformances, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.

Key Responsibilities:

• Lead complex multi-functional project teams.
• Creates reports to escalate to management, along with status updates relative to success in meeting critical goals and objectives.
• Implements best practices for process validations on all ongoing Technology Transfer and lifecycle project initiatives.
• Counsels and corrects, in a timely manner, any process issues or concerns to the next management level.
• Coaches and trains junior colleagues in techniques, processes, and responsibilities.
• Provides technical direction to ensure the application of relevant technical platform standards for drug substance processes.
• Develop expert knowledge in platform drug substance manufacturing processes and equipment and act as an authority in case of solving issues, as well as developing improvements
• Identify and deploy digitalization and system integration concepts to improve the digital maturity of the MSAT team, moving from manual, paper-based and/or isolated processes to higher levels of digitization and automation.
• Perform process analysis, calculate high level business cases to assess potential projects, assess solutions, and collect user requirements to drive process improvement and manufacturing data projects.
• Enable the readiness of piloted innovative technologies and drive the implementation into our portfolio. Define a strategy to adopt new technologies and enable interactions with quality groups and health authorities.
• Identify and assess potential risks to product quality and regulatory compliance associated with process changes or deviations.
• Lead multidisciplinary product sub-team teams in support of new product introduction, technical transfer, and commercial manufacturing operations.
• Interpret and implement industry and regulatory guidance for drug substance manufacture, ensuring compliance with GMP, quality, and scientific principles
• Leverage networking and influencing skills to ensure effective collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, Procurement and Regulatory

Qualifications

Education:

• Minimum of Bachelor's degree or equivalent University degree in a related field

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience required.
• Proven experience in drug substance technology transfer
• Experience with (bio)pharmaceutical manufacturing processes and strong understanding of regulatory requirements (e.g., GMP, ICH)
• Demonstrated experience leading complex multi-disciplinary projects and/or initiatives
• Proficiency in data analysis, decision making, and problem-solving skills
• Excellent written/oral communication and interpersonal skills to effectively collaborate with cross-functional teams
• Project management skills with strong attention to detail and organizational skills
• Expertise on system integration and digitalization concepts

Other:

• Fluent in English, written and spoken
• May require up to 25% 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 & 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 , internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$100,000 to $172,500

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. 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.