Validation Engineer

Overview

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.

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.

• 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

• N/A.

• Bachelor's degree in engineering and a minimum of two years of relevant industry experience in manufacturing, process development, scale-up, technology transfer, or process validation.
• Previous 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.

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

• Sedentary work, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
• When in the lab, employees will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exerting up to 10 pounds of force constantly to move objects, when working in the lab.
• The employee is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
• Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• The employee is not substantially exposed to adverse…