Johnson & Johnson is hiring for a Principal Engineer - MSAT Materials! This position is located in Malvern, Pennsylvania; alternate work location may be considered in Horsham, Pennsylvania and Titusville, New Jersey. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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/.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
Are you interested in joining a team that is positively impacting patients' lives by ensuring efficient and effective manufacturing of our biopharmaceutical products? Apply now for this exciting chance to join our new MSAT Materials team!
Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT), the MSAT Materials team is responsible for management and optimization of raw materials in Large Molecule Drug Substance and Drug Product commercial supply chain. The MSAT Materials Principal Engineer will join a brand-new team in shaping and implementing the technical, business and quality requirements for life cycle management of raw materials.
Key Responsibilities:
- Owner of Lifecycle Management (LCM) raw material control strategy including supplier/material reliability, specification management, and critical material attribute monitoring
- Evaluate the changes to raw materials, considering factors such as quality, purity, and performance.
- Identify and assess potential risks on product quality and regulatory compliance associated with raw materials, including supply chain disruptions, quality issues, and regulatory changes.
- Develop mitigation strategies to minimize risks and ensure business continuity.
- Lead multidisciplinary product sub-team teams for raw material readiness in support of new product introduction, technical transfer, and commercial manufacturing operations.
- Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
- Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, Procurement and Regulatory
Qualifications
Education:
- Minimum of a Bachelor's/University or equivalent degree required; Master's or focused degree preferred in Chemistry, Biology, Materials Science, Engineering, Pharmacy/Pharmaceutics, or related field
Experience and Skills:
Required:
- Minimum 6 years of relevant work experience
- Experience with (bio)pharmaceutical manufacturing processes and strong understanding of regulatory requirements (e.g., GMP, ICH)
- Raw material expertise (such as with: cell culture media, chemicals, polymeric contact materials, and/or excipients) and understanding of the impact of changes on functionality and stability in the biotherapeutics manufacturing process
- Demonstrated experience leading 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
- Strong attention to detail and organizational skills
- Ability to work independently and manage multiple tasks simultaneously
Preferred:
- Competencyand experience in quality investigations and deviations, material change risk assessments, and/or regulatory questions and submissions
- Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies
Other:
- May require up to 10% domestic and international travel, depending on business needs and work location
Why Johnson & Johnson
The anticipated base pay range for this position is $100,000 to $172,500.
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)).
This position is eligible to participate in the Company's long-term incentive program.
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
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal, and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.
This job posting is anticipated to close on January 06, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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.