Computer System Validation Senior

Position: Senior CVS Specialist (Computerized Validation Systems)

We are seeking a Senior CVS Specialist to join our global team. This is an exceptional opportunity to tackle complex, international challenges in the pharmaceutical and chemical industries, working with cutting-edge technologies in a dynamic and high-performance environment.

Key Requirements:

• Education: Bachelor's degree in Chemistry, Engineering, or related field.

• Experience:

  • Extensive experience in the pharmaceutical industry, with strong knowledge of pharmaceutical and chemical business processes, including manufacturing, regulatory compliance, and quality systems (GxP, validation, quality management systems, GMP Annex 11, 21 CFR Part 11, Data Integrity Principles, GAMP 5, etc.).
  • Proven track record in computerized systems validation (ERP, eDMS, eQMS, LIMS, laboratory systems, EBRMES, SCADA, etc.).
  • Expertise in data integrity assessments and remediation initiatives.
  • Proficiency in managing changes and incidents within computerized systems.
  • Experience with IT infrastructure projects and familiarity with Agile methodologies is highly advantageous.

• Language Proficiency: Fluent in Spanish and English. Additional languages are highly desirable.

• Attributes:

  • Strong learning orientation and motivation to tackle new technical challenges.
  • Availability of a personal vehicle.

What We Offer:

• Compensation & Benefits: Competitive salary based on experience, additional extra-legal vacation days, and a comprehensive benefits package.

• Work Environment:

  • Global Presence: Join a rapidly expanding, multinational organization with a diverse, multicultural team.
  • Work Flexibility: Hybrid working model with a flexible schedule, including reduced hours on Fridays.
  • Team Collaboration: Engage with a team of highly experienced professionals committed to knowledge-sharing and teamwork.

• Professional Development:

  • Learning & Growth: Structured training programs and continuous development opportunities.
  • Language Enhancement: English and Chinese language lessons available.

• Corporate Culture:

  • Regular team-building activities and social events to foster collaboration and engagement.
  • Positive and dynamic work environment with a team of enthusiastic and driven consultants.

Join us and be part of a technical challenge that will shape the future of pharmaceutical and chemical industries worldwide!

Montreal Associates is acting as an Employment Agency in relation to this vacancy.