2025-01-23 11:16:08

Cleaning Validation Specialist

CVMarket.lt Client
1800 - 2600 €/m Gross

Job Description

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

 

The opportunity

The Cleaning Validation Specialist will be a key player in ensuring the cleanliness and sterility of manufacturing equipment and environments that support our pharmaceutical processes. This role is critical for maintaining compliance with regulatory and industry guidelines, ensuring the safety and quality of our products.

 

How you’ll spend your day 

  • Develop and execute cleaning validation strategies, ensuring compliance with regulatory standards such as FDA 21 CFR Parts 210, 211, and other relevant guidelines.
  • Generate, review, and approve validation documentation, including Validation Plans, Risk Assessments, SOPs, Protocols, and Validation Reports.
  • Conduct periodic reviews of validated cleaning processes to ensure ongoing compliance and revalidate as needed.
  • Coordinate with cross-functional teams, including Manufacturing, QA, and Engineering, to implement and sustain validation activities.
  • Investigate and resolve discrepancies or anomalies during validation exercises.
  • Stay updated with emerging regulations and best practices in cleaning and process validation.
  • Provide training for relevant stakeholders on cleaning and process validation principles and best practices.
  • Support internal and external audits by offering expertise and documentation related to cleaning and process validations.
  • Also additionally plan and coordinate periodic qualification of critical systems (HVAC, WFI, PST etc) as well as process validation.

Requirements

Your experience and qualifications

  • Bachelor’s or higher degree in Chemistry, Biology, Engineering, or a related scientific field. Final-year students are also welcome to apply.
  • Excellent communication skills, both written and verbal.
  • Strong computer skills, proficient in MS Office and general Windows applications.
  • Ability to work independently, organize, and summarize information effectively in both written and verbal formats.
  • Strong analytical, problem-solving, and organizational skills.
  • Familiarity with cGMP guidelines, pharmaceutical manufacturing processes, and equipment.
  • Good English and Lithuanian language

Nice to have

  • Initial experience in manufacturing activities or quality control  in the pharmaceutical sector.
  • Initial experience in cleaning validation in the pharmaceutical sector.
  • Knowledge of relevant guidelines such as ICH Q9 for Quality Risk Management.

Company offers

 Enjoy a more rewarding choice

  • Salary between 1800 - 2600 Euro gross monthly. 
  • Benefits package: health and accident insurance, additional health and vacation days (for worked years).
  • Highly professional team and organizational culture with strong values.
  • Personal and professional development within the company.
  • Work model supporting work life balance.
  • Employee rewards and recognition programs, events and social activities.