SENIOR ENGINEER, VALIDATION & CPV

Johnson & Johnson Innovative Medicine is recruiting for a Senior Engineer Validation and Continued Process Validation to be based in Beerse, Belgium, Leiden, Netherlands or Schaffhausen, Switzerland or Beerse, Belgium.
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.
As an Engineer reporting into the MSAT LM Cross Platform Engineering group, you will hold a strategic and tactical role within Global MSAT and will partner with R&D, Make functions, New Product Introduction, the Quality Organization and Value Chain Management teams, as well as internal manufacturing sites, external partners, such as contract manufacturing organizations, to develop and implement robust manufacturing processes.
You will team-up to deliver short-to-long term pipeline of initiatives associated to Johnson & Johnson large molecule and parenteral product strategy and grow.
Key Responsibilities.
Single Point of Contact (SPOC) for MSAT needs for LM and parenteral products regarding Life Cycle Process Validation (LCPV) and Continued Process Verification (CPV).
Manage communities of practices and know-how around LCPV and CPV within the firm, maintain current internal guidance on LCPV and CPV.
Proactively promote quality and compliance in the areas of LCPV and CPV and coach others to do the same.
Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations regarding criticality analysis, control strategy, validation and CPV by means of coordinating technical writer work.
Qualifications Specific knowledge Expertise on pharmaceutical manufacturing processes and products.
Knowledge of Quality & Compliance / regulatory requirements (GMP) especially for life cycle process validation and quality risk management.
Process excellence (6sigma) and statistical understanding.
Project management (FPX), organizing, planning and coordination skills.
Personal and interpersonal skills skills Ability to work in a cross functional / cross-regional project team.
Ability to manage complexity and change Ability to interact at different levels of the organization.
Ability to work under pressure, handle conflicting interests, and take decisions.
Customer and business focus, team player.
Personal attitude and mindset Drives for innovation and change to ensure competitiveness.
an-do mentality, agility & flexibility able to work with stretched goals and deadlines.
Willing to place the goals of the team first and work with others towards these goals.
Communicative / Motivator / Negotiator / assertive person having impact.
Showing a high sense of responsibility regarding professional activities.
Education.
Undergraduate degree in Science, Engineering, Business or Supply chain subject areas required.
Post-graduate degree preferred.
#LI-MV2 #LI-Hybrid