Ardena Careers · 6 hours ago
Manufacturing Engineer
Somerset, NJ
Contract
Onsite
Entry, Mid Level
$90K/yr - $95K/yr
2+ years expArdena is a leading Contract Development and Manufacturing Organization (CDMO) that partners with pharmaceutical companies to help biopharma innovators navigate drug development. The Manufacturing Engineer role involves supporting GMP pharmaceutical and chemical processing operations by optimizing processes, designing and qualifying equipment, and troubleshooting issues.
Pharmaceuticals
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 Careers
Find your career path with Ardena At Ardena, we’re more than a global Contract Development and Manufacturing Organization (CDMO)—we’re a team of innovators, problem-solvers, and experts dedicated to advancing drug development.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase