Validation Engineer I - Process Validation & Tech Transfer

Supernus Pharmaceuticals, Inc.; Rockville (MD); On-site; USD 74,000 - 85,000; Full time

Job summary

Supernus Pharmaceuticals, Inc. is seeking a Validation Engineer I to drive process development, validation, and technology transfer within the Drug Delivery Sciences department.

You will lead pre-validation studies, collaborate with CMOs for scale-up, and support in-house formulation and regulatory documentation. Ideal candidates have a Bachelor’s in engineering with 2+ years in manufacturing/validation, strong data analysis skills, and experience documenting validation activities.

Qualifications

• Bachelor’s degree in engineering with 2+ years in manufacturing/validation.
• Experience writing validation protocols and technical reports.
• Knowledge of cGMP in Drug Product manufacturing.
• Strong data-driven problem solving and analytical skills.
• Experience with statistical analyses and models is a plus.
• Excellent written and verbal communication; proficient in Word/Excel.

Responsibilities

• Develops statistical analyses (DOE/SPC) to improve manufacturing processes.
• Leads pre-validation studies and identifies critical process parameters at CMOs.
• Writes and reviews study protocols, reports, and validation docs.
• Reviews manufacturing batch records, protocols, and reports.
• Supports process tech transfer to CMOs.
• Assists with scale-up, process registration, and validation at CMOs.
• Writes equipment qualification docs, SOPs, and work instructions.
• Collaborates across functions to supply CTM for clinical programs.
• Writes relevant quality sections of regulatory filings.

Skills

DOE

SPC

cGMP

Technical writing

Education

Bachelor's in Engineering

Tools

MS Office

Job description

Supernus Pharmaceuticals, Inc. is seeking a Validation Engineer I to drive process development, validation, and technology transfer within the Drug Delivery Sciences department.

You will lead pre-validation studies, collaborate with CMOs for scale-up, and support in-house formulation and regulatory documentation. Ideal candidates have a Bachelor’s in engineering with 2+ years in manufacturing/validation, strong data analysis skills, and experience documenting validation activities.