MSAT SM DP TO SENIOR / PRINCIPAL PROCESS ENGINEER

Johnson & Johnson Innovative Medicine is recruiting for a MSAT Small Molecule Drug Product Technical Owner (Senior – Principal Process Engineer), to be located in Beerse or Schaffhausen.
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.
nj.
om/.
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.
Manufacturing Science and Technology (MSAT), being part of the Innovative Medicine Supply Chain (IMSC) and, a member of the Johnson & Johnson Family of Companies, As the Drug Product Technical Owner (DPTO), you have overall accountability to provide technical support for marketed products under your responsibility including implementation of new innovations & technologies.
The DPTO is the voice of MSAT in the Value Stream team and responsible for the technical aspect of the complete Lifecycle Management structure and strategy of drug product.
Objectives of the Position Represents MSAT and the parenteral technical team in the value chain stream, own the coordination of all product related technical activities and participates in development of long- term supply strategy including scenario development and E2E impact analysis.
Supports and /or leads manufacturing process related investigations, issue management including concerns of quality or compliance events for SM Parenteral drug products Function as the primary point of contact, leading or supporting all E2E technical matters including technology transfer projects, process improvements, and technology strategy roadmaps Creates and maintains product technical knowledge and supports the knowledge as an element of the overall value chain knowledge infrastructure Partners with a multi-disciplinary local/global teams of technical experts in the following areas.
MSAT SM/LM Platforms, manufacturing site representatives, R&D, product stability, regulatory and Q&C.
Monitors technical process and product performance across internal and external manufacturing sites including technical product and process risk profiles and owning the criticality analysis Contribute, review, and approve drug product technical and regulatory documents for routine technical support, change controls and trials for integration of supply chain technical expertise into project execution at the manufacturing site level.
Identify and implement opportunities for active decrease of COGs and partner with development and supply chain groups to implement strategies to improve process robustness, optimizations, and implementation of new technologies into the supply chain.
Supports regulatory audits and inspections, including at external sites.
Qualifications What you will need to succeed Ability to foster team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the various collaborators, and influence with or without direct authority.
Motivated, self-starter, quality driven and able to work independently with proven problem-solving skills.
Minimum of a Bachelor's/University or equivalent degree (required).
M.
.
or PhD (preferred).
5 years of relevant work experience with pharmaceutical product manufacturing / MSAT functions, or equivalent (required).
Experience with technical transfer/process optimization at manufacturing sites (required) Experience with major parenteral process investigations, root cause analysis methods and statistical tools (required) Knowledge of Regulatory guidance related to aseptic processing, validation, manufacturing site systems and procedures, including an understanding of cGMP requirements (required) Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Trackwise, and/or Planisware (preferred).
FPX, PMP, or equivalent Project Management certification (preferred).
Proficiency in English (required) May require up to 25% domestic and international travel, depending on project needs.
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