Introduction to Ardena

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
 

For the Ardena Business Unit based in Somerset (US), we are looking for a Senior Validation Engineer, Equipment/Facility.

WHAT YOU WILL WORK ON

YOUR KEY RESPONSIBILITIES

• Preparation/ execution IQ/OQ/PQ protocols for equipment, instrument, facility and utilities (HVAC, Building Automation System, Compressed Air, Nitrogen system, and Environmental Monitoring) as well as related software to ensure compliance and adherence to CGMP and Ardena validation standards.
  
• Identify and resolve non-conformances/deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
  
• Help generate qualification report and help summarize the results which will be reviewed by the supervisor.
• Knowledge of PLC, HMI and equipment software is required.
• Knowledge of 21CFRPart11 and Data Integrity is required.
• Work collaboratively to meet Equipment and Facility Validation deadlines, write reports, give presentations and maintain knowledge and information in area of expertise.

YOUR PROFILE 

• Bachelor’s Degree in a technical discipline is required. Masters is preferred.
• 5 years of validation industry experience is required.
• 5 years in CGMP-related industry is preferred.
• Experience in oral solid dosage forms will be plus.
• Code of Federal Regulations and CGMP’s relating to the field of validation.
• In depth knowledge of FDA guidelines and ISPE guidelines.
• Strong verbal and written communication skills is a must; ability to interface with all levels of the organization
• Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-75 pounds.
• Fluent in English is required.                                                                                                                                                                          
  
  

 WHAT WE OFFER

At Ardena, we recognize that our people drive our success. We offer:

✔ A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefits effective day one of employment
✔ Paid Time Off
✔ A dynamic, international work environment with career growth opportunities
✔ Access to Ardena Academy, our internal learning platform for professional development
✔ A chance to contribute to groundbreaking drug development projects that make a real impact

HOW TO APPLY

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!