Principal Validation Engineer

at  Johnson Johnson

Abiomed, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Process Validation Engineer, to be located in Aachen, Germany.
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/.
I Am Abiomed | I Am Heart Recovery | Patients First!
We are currently seeking a highly skilled and experienced Senior Process Validation Engineer to join our team at Johnson & Johnson. This is a unique opportunity to contribute to our world-class manufacturing operations in Germany.

Responsibilities:

• Take charge of the validation efforts for new manufacturing processes, guaranteeing adherence to regulatory standards and widely accepted guidelines in the industry.
• Develop and implement process validation protocols and reports, carefully documenting findings and ensuring successful implementation.
• Collaborate with cross-functional teams to determine validation requirements and timelines.
• Conduct risk assessments and implement mitigation strategies to ensure the successful implementation of validated processes.
• Continuously improve and optimize existing manufacturing processes to drive efficiency and quality.
• Offer technical expertise and guidance to colleagues within the company, ensuring compliance with validation protocols and procedures.
• Stay up-to-date with industry trends and regulatory changes to proactively identify areas for improvement.

QUALIFICATIONS

• Bachelor’s degree in Engineering or related field; Master’s degree preferred.
• Minimum of 10 years of experience in process validation (including TMV, CSV) within a manufacturing environment.
• Proven track record of successfully implementing process validation strategies and protocols.
• Strong knowledge of regulatory requirements and industry standards related to process validation.
• Exceptional problem-solving skills and attention to detail.
• Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Strong motivation to succeed and a dedication to achieving high standards.
• Fluency in both written and spoken English and German.
  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

• Take charge of the validation efforts for new manufacturing processes, guaranteeing adherence to regulatory standards and widely accepted guidelines in the industry.
• Develop and implement process validation protocols and reports, carefully documenting findings and ensuring successful implementation.
• Collaborate with cross-functional teams to determine validation requirements and timelines.
• Conduct risk assessments and implement mitigation strategies to ensure the successful implementation of validated processes.
• Continuously improve and optimize existing manufacturing processes to drive efficiency and quality.
• Offer technical expertise and guidance to colleagues within the company, ensuring compliance with validation protocols and procedures.
• Stay up-to-date with industry trends and regulatory changes to proactively identify areas for improvement