Validation Engineer I

Validation Engineer I

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Validation Engineer I supports activities within the Drug Delivery Sciences department related to process development, validation, and technology transfer. This role will develop, lead, and execute pre-validation studies and engineering activities. In addition, this role will partner with contract manufacturing organizations (CMOs) to support manufacturing scale up and operations readiness. Incumbents in this role will support in house formulation and process development, author sections of regulatory filing documents, and collaborate cross functionally to ensure timely delivery of clinical trial materials.

Essential Duties & 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).
• Assists with manufacturing scale-up manufacturing, process registration, and process validation activities at CMOs.
• Recommends and implements equipment and manufacturing processes to ensure successful process technology transfer, process registration, and validation.
• Writes and reviews of equipment qualification documents, Standard Operating Procedures (SOPs), and work instructions.
• Collaborates cross functionally to support the manufacture of Clinical Trial Materials (CTM) and ensure the timely delivery to clinical programs.
• Writes and reviews relevant quality sections of regulatory filing documents (IND, NDA, Briefing packages, IMPD, CTA, etc.).
• Support early phase product and process development in collaboration with Drug Delivery Sciences teams.
• Other duties as assigned.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.