Description

Johnson & Johnson is currently seeking a Principal Validation Engineer (m/f/d) to join our Abiomed Team 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/.

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

Requirements:

• 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.