Senior QA Engineer

Unither Pharmaceuticals•Silver Spring, MD

9d•$92,500 - $125,000•Onsite

About The Position

United Therapeutics (Nasdaq: UTHR) is a public benefit corporation focused on developing novel pharmaceutical therapies and technologies for rare, deadly diseases and to address the shortage of transplantable organs. The company has six FDA-approved therapies and is working on manufactured organs to eliminate transplant waiting lists. The Senior Quality Engineer will play a crucial role in shaping the future of new APIs, drug products, and combination products from development through commercialization. This role involves leading investigations, approving critical GMP documentation, and serving as an on-site partner to CMC and CMOs. The position requires a strategic presence during regulatory inspections and acting as a subject matter expert for complex quality challenges. The ideal candidate is a sharp problem-solver who thrives on ownership, collaboration, and continuous improvement.

Requirements

Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
5+ years of relevant pharmaceutical industry experience in a cGMP environment with a Bachelor's Degree or 3+ years of relevant pharmaceutical industry experience in a cGMP environment with a Master's Degree
4+ years of experience in Quality Assurance, Quality Engineering, Validation or a Technical Operations role
Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards
Ability to define problems, collect data, establish facts, and draw valid conclusions
Strong organizational skills and strong attention to detail
Strong verbal and written communication skills
Strong interpersonal skills and ability to work as an effective team member
Ability to actively participate in process improvement
Strong technical writing skills
Working knowledge of US FDA, EU, and JP GMP regulations
Proficient in Microsoft Excel, Word, PowerPoint and Adobe Acrobat
Ability to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines

Nice To Haves

Master’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
Experience with aseptic processing and media fill programs
Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise and Empower software systems
Familiar with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, medical devices, and combination products
Previous experience with validation and facility qualification
Previous experience in regulatory inspections
Process start up and clinical trial material manufacturing experience
Experience performing technology and product transfers
Continuous process verification
Knowledge of software validation practices and data integrity initiatives

Responsibilities

Support the development of new active ingredients, drug products, and combination products through design and development, implementation of process verification and validation activities, and commercialization.
Maintain and improve currently marketed products.
Implement standards, methods, and procedures for product development.
Collaborate and approve GMP related documents (i.e. IOQ and PQ documents, process validation protocols, analytical/microbiological method validations, stability protocols, operational protocols and reports, etc.) pertaining to chemical intermediates APIs and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs.
Lead or collaborate on investigations for quality events, investigations, out of specifications (OOS), change controls, exceptional conditions, and corrective and preventive action (CAPA) processes for cGMP events.
Create or assist in the creation of batch records, protocols, summary reports, standard operating procedures, raw material specifications, etc.
Provide QA Engineering input to process and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Participate in project initiatives, project start-up, and continuous process verification.
Serve as an on-site contact for CMC personnel.
Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations.
Support QE management during regulatory agency inspections (FDA, MHRA, etc.) and participate in the closure of internal and regulatory audit observations.
Oversee CMO related manufacturing processes, change controls, investigations, and new projects.
Perform “in-plant” activities as needed to support operational processes critical to product quality.
Support SME in change management activities and communicate and resolve quality issues with internal departments.
Escalate complex issues to Quality Management.
Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.