Ardena · 2 hours ago
Manufacturing Engineer
Somerset, NJ
Full-time
Onsite
Entry, Mid Level
$90K/yr - $95K/yr
2+ years expArdena is a leading Contract Development and Manufacturing Organization (CDMO) partnering with pharmaceutical companies to navigate drug development. The Manufacturing Engineer will support GMP pharmaceutical and chemical processing operations by optimizing processes, designing and qualifying equipment, troubleshooting issues, and supporting technology improvements.
Health CarePharmaceutical
Responsibilities
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
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+)
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
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
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
Qualification
Required
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
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
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
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
Preferred
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
Benefits
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
Company
Ardena
We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines.
501-1000 employees
H1B Sponsorship
Ardena has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2020-01-09Acquired
Leadership Team
Jeremie Trochu
Chief Executive Officer
Dipesh Patel
Chief Quality Officer
Recent News
Ardena Holding NV.
2025-11-03
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