Validation Engineer I — Process Validation & Tech Transfer

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401k match

Life insurance

Stock options

Employee stock purchase program

Discretionary bonus

Job summary

Supernus Pharmaceuticals Inc in Rockville, MD seeks a Validation Engineer I to advance drug delivery processes through pre-validation studies, DOE and SPC, and to partner with CMOs for scale-up and technology transfer, including in-house formulation and process development support.

The role involves writing study protocols, technical reports, validation documentation, and regulatory filing sections, plus cross-functional collaboration to ensure timely delivery of clinical trial materials.

Qualifications

• Bachelor’s degree in engineering with at least two years of relevant industry experience in manufacturing, process development, scale-up, technology transfer, or process validation.
• Experience writing equipment validation protocols or technical writing.
• Working knowledge of cGMP requirements related to Drug Product manufacturing processes.
• Demonstrated ability to solve complex technical problems with the use of data.
• Previous experience working with Statistical models and conducting statistical analyses a plus.
• Strong written and verbal communication skills are required.
• Proficiency with Microsoft office suite (Word, Excel, Outlook) required.

Responsibilities

• Develops and conducts statistical analyses, including Design of Experiments (DOE) and Statistical Process Controls (SPC) to evaluate and improve manufacturing processes.
• Leads pre-validation studies and engineering batches to identify and define critical process parameters of a process at Contract Manufacturing Organizations (CMO).
• Write and review study protocols, technical reports, and validation documentation to ensure alignment with regulatory and quality standards.
• Reviews and approves manufacturing batch records, protocols, and reports.
• Supports process technology transfer to Contract Manufacturing Organization (CMO).

Skills

Statistical analyses

Design of Experiments

SPC (Statistical Process Control)

Technical writing

Communication skills

Problem solving with data

Microsoft Office

Education

Bachelor’s degree in engineering

Job description

Supernus Pharmaceuticals Inc in Rockville, MD seeks a Validation Engineer I to advance drug delivery processes through pre-validation studies, DOE and SPC, and to partner with CMOs for scale-up and technology transfer, including in-house formulation and process development support.

The role involves writing study protocols, technical reports, validation documentation, and regulatory filing sections, plus cross-functional collaboration to ensure timely delivery of clinical trial materials.