Supernus Pharmaceuticals, Inc. · 2 weeks ago
Validation Engineer I
Rockville, MD
Full-time
Onsite
Entry Level
$73K/yr - $85K/yr
2+ years expSupernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience in developing products for CNS diseases. The Validation Engineer I will support activities related to process development, validation, and technology transfer, collaborating with contract manufacturing organizations to ensure successful manufacturing operations.
BiotechnologyHealth CarePharmaceutical
No H1B
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
Qualification
Required
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
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
Preferred
Previous experience working with Statistical models and conducting statistical analyses a plus
Benefits
Health
Dental
Vision
Paid time off
401k company match
Company paid life insurance
Health and wellness benefits
Stock equity awards
Employee stock purchase programs
Participation in our Company’s discretionary annual bonus program
Company
Supernus Pharmaceuticals, Inc.
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$689.5MKey Investors
UBSNew Enterprise Associates
2023-02-14Post Ipo Debt· $150M
2018-03-13Post Ipo Debt· $350M
2013-04-24Post Ipo Debt· $90M
Leadership Team
J
Jack A. Khattar
President & CEO
F
Frank Mottola
Chief Technical Operations Officer
Recent News
2025-12-08
Company data provided by crunchbase