Validations Engineer

Technical Validations Technician

Expect to grow, personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to demonstrate your talent. As a trusted and respected partner in the pharmaceutical industry, we maintain the highest standards in safety, quality, and sustainability, while fostering a culture that empowers you to thrive. Join a global company in rapid expansion, where diverse perspectives and experiences come together in a collaborative environment.

Here you will find a workplace that values both collective success and your individual contributions, offering long-term opportunities to grow and make an impact.

Your Role:

At Siegfried, we are looking for a Technical Validations Technician to join our Quality department at the Masnou site. Your main duties will include the execution and management of validation activities for processes (manufacturing, cleaning, and sterilization processes) and change management to comply with cGMP requirements in time and quality, ensuring that the site validation programs meet global regulatory expectations.

Key responsibilities include:

• Identifying applicable process parameters and the control strategy of the process in a focused validation plan for process validation.
• Providing technical expertise and facilitating the establishment of quality risk assessments (when necessary).
• Validation:
  Managing validation planning through the writing and maintenance of master validation plans for process validation, as well as continuous verification.
• Managing the lifecycle activities of process validation ensuring that it remains in a state of control through continuous process verification.
• Ensuring that the right variables are identified for continuous monitoring as a contribution to quality risk management activities.
• Drafting and reviewing validation protocols and reports for processes, as well as continuous verification protocols and reports.
• Carrying out the execution of validation activities on site.
• Supporting the validation lead in the preparation of KPI reports.
• Reviewing master batch records and associated change controls. Confirming the need for revalidation based on technical changes.
• Ensuring all activities and projects under your responsibility are completed for inspections.
• Providing technical expertise (and, where applicable, facilitating) pre-validation risk assessments using risk management tools.
• Working collaboratively and cross-functionally to ensure process risks are adequately analyzed, controlled, and documented correctly.
• Ensuring all site validation activities are performed in accordance with current Siegfried global requirements and cGMP; managing deviations associated with process validation and making recommendations for resolution and prevention of recurrences.
• Working closely with the technical transfer group and new product launches, ensuring the transfer of knowledge, adequacy of control strategies, risk analysis and control, and that commercial processes are ready for validation.
• Participating in pre-validation activities and risk assessments to ensure the success of commercial process validation.

Your Profile:

Requirements for the position:

• Education:
  
  Degree in Pharmacy, Chemical Engineering, or Pharmaceutical Technology
• Languages:
  
  Spanish and English at First Certificate level.
• Previous experience: 2-3 years in a validation department (validation of manufacturing, cleaning, and sterilization processes).
• Knowledge of manufacturing processes and associated equipment.
• Solid practical knowledge of quality systems and regulatory requirements of multiple health authorities.
• Expert in reviewing and writing technical reports.
• Demonstrated experience in project management in multifunctional environments (e.g., multi-site, technical development, or other functions).
• Fundamental understanding of standard analytical assays in the pharmaceutical industry.

Your Benefits:

We offer:

• Flexible schedule including entry from 7:30 to 9:30 AM and exit from 4:00 to 6:00 PM, and on Fridays with the possibility of an intensive day from 7:00 to 3:00 PM.
• Two days of telework per week.
• Medical insurance.
• Life and accident insurance.
• Subsidized canteen.
• Pension plan.

Founded in 1873 in Zofingen, Switzerland, Siegfried has become a global network with 13 centers on three continents. With a team of more than 3,800 highly trained professionals, we bring our pharmaceutical clients' innovations to an industrial scale and manufacture safe medicines for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations that can currently carry out the development and manufacturing of active pharmaceutical ingredients (APIs) and finished dosage forms under one roof.

This unique combination of knowledge and experience makes us the most reliable partner in the pharmaceutical industry.