Demo

Senior Analyst, Engineering Compliance

Ardena
Franklin, NJ Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

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 Analyst, Engineering Compliance.

WHAT YOU WILL WORK ON

YOUR KEY RESPONSIBILITIES

  • Oversee the CMMS system, ensuring accurate data entry, preventive maintenance scheduling, and work order tracking.
  • Maintain and update equipment records, job plans, spare parts inventory, and asset management databases.
  • Coordinate preventive, predictive, and corrective maintenance programs to optimize equipment performance and minimize downtime
  • Ensure maintenance operations comply with OSHA, GMP, FDA, and corporate policies.
  • Track and analyze KPIs related to equipment reliability, work order completion rates, and maintenance costs.

YOUR PROFILE

  • High school diploma or equivalent required with 10 years of relevant experience.
  • Bachelor's degree in Engineering, Facilities Management, Maintenance, or a related field preferred with a minimum of 5 years of experience in maintenance planning, CMMS administration, or engineering compliance within a manufacturing, pharmaceutical, or industrial environment.
  • Strong understanding of GMP, FDA, OSHA, and other industry regulations.
  • Strong proficiency in CMMS systems, data analysis, and reporting tools.
  • Ability to occasionally lift up to 25 lbs.
  • Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent.
  • 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, global 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!

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