Introduction to Ardena 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 Manufacturing Engineer. What you will work on Your role The Manufacturing Engineer supports Ardena’s GMP pharmaceutical and chemical processing operations by optimizing processes, designing and qualifying equipment, troubleshooting issues, and supporting technology improvements. This role ensures high-performance, audit ready production environments across oral solid dose, chemical processing, and modernization initiatives. Your key responsibilities Process Engineering & Optimization Analyze pharmaceutical and chemical processing workflows to reduce variability and improve throughput and yield. Apply Lean, Six Sigma, and CI methodologies within GMP environments. Maintain and optimize CPPs/CQAs, supporting CPV programs. Revise batch records, SOPs, and controlled documents. Improve operator ergonomics, safety, and line performance. System & Equipment Engineering Specify, procure, and qualify equipment per sanitary design and contamination-control requirements. Lead commissioning & qualification (IQ/OQ/PQ). Support automation and data integrity compliance (ALCOA+). Troubleshooting & Investigations Lead RCA investigations using 5Why, Fishbone, etc. Own and execute CAPAs for sustainable improvements. Provide on-floor engineering support to minimize downtime. Partner with QA/Validation/Maintenance on deviations and equipment failures. Project Engineering & Technology Deployment Manage equipment upgrades, modernization, and facility modifications. Support tech transfer, scaleup, and NPI. Lead risk assessments and engineering change controls. Maintain project schedules, budgets, and documentation. Quality, Compliance & Documentation Ensure adherence to FDA, EMA, ICH, ISO, and internal standards. Support audits and implement corrective actions. Drive process validation including characterization studies and PPQ. Maintain strong documentation standards supporting data integrity. Your profile Education & Experience Bachelor’s degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering preferred. 2–5+ years of experience in pharmaceutical, chemical, or other regulated GMP manufacturing environments. Experience with granulators, mixers, tablet presses, chemical reactors, extruders, or packaging lines. Lean/Six Sigma experience preferred. Hands-on experience with statistical software such as Minitab, JMP, or equivalent tools. Automation, SCADA, or MES experience a plus. Knowledge & Skills Strong knowledge of cGMP, validation practices, and regulatory expectations (FDA/EMA/ICH). Proficiency in statistical analysis, including SPC, control charting, trend evaluation, and process capability (Cp/Cpk/Pp/Ppk). Experience performing Design of Experiments (DOE) and interpreting results to drive process understanding and optimization. Skilled in using statistical software (e.g., Minitab, JMP) for data modeling, multivariate analysis, and CPV trending. Ability to interpret complex data sets from chemical and pharmaceutical processes, applying regression, correlation, and MVDA techniques. Experience applying statistical principles within risk assessments (FMEA, risk matrices, fault‑tree analysis). Strong documentation, technical writing, and data integrity discipline (ALCOA+). Proven capability in cross-functional collaboration and project execution. Physical Requirements Ability to move throughout manufacturing and cleanroom areas, including standing or walking for extended periods. Ability to lift up to 25 lbs. occasionally. Ability to bend, reach, or access equipment during troubleshooting or inspections. Ability to work around manufacturing equipment, chemicals, and powders while wearing required PPE (gowning, gloves, safety glasses; respirator if needed). Ability to visually inspect equipment and hear alarms or equipment cues in moderate‑noise environments. Work Environment & Safety Conditions Works in office, manufacturing, and cleanroom areas as needed. Exposure to equipment noise, powders, chemicals, and cleaning agents with proper PPE. Must follow all GMP, safety, and EHS procedures while working around active processes and machinery. Required use of PPE such as gowns, gloves, safety glasses, and other protection based on area and task. 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 The salary range for this role is $90,000.00 - $95,000.00 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! #J-18808-Ljbffr