Senior Quality Project Engineer

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The Job Details are as follows: What we do United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens having a positive impact on patients, the environment and society will sustain our success in the long term. We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of medicines for life. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases. How youll contribute The Senior Quality Project Engineer will support the development of new active ingredients, drug products, and combination products through the design and development, implementation of process verification and validation activities and commercialization, including maintenance and improvement of currently marketed products with a focus on third party/CMO projects. This individual will be responsible for the implementation of standards, methods, and procedures for product development. - Act as the main point of contact for UTC offsite operations and collaborate with Project Management to ensure critical timelines are met - Provide oversight to CMO related manufacturing processes, change controls, investigations, and new projects. Perform in-plant activities as needed to support operational processes critical to product quality - Collaborate and approve GMP related documents (i.e. IOQ and PQ), 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 (as applicable) - Lead or collaborate on investigations for Quality Events, Investigations, Out of Specifications (OOS), Change Controls, and Corrective and Preventive Action (CAPA) processes for cGMP events - Create or assist in the creation and maintenance of Batch Records, Standard Operating Procedures, Protocols, Summary Reports, etc. - Provide 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 quality system project initiatives and continuous process verification - On-site contact for CMC personnel - Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations. Provide support during supplier/CMO audits - Provide support to QE management during regulatory agency inspections. (FDA, MHRA, etc.) and participate in the closure of internal and regulatory audit observations - Other duties as assigned For this role you will need Minimum Qualifications - Bachelor of Science (B.S) Degree in Engineering, Chemistry, Biology, Biochemistry, or related discipline - 8+ years of relevant pharmaceutical industry experience in a cGMP environment - 4+ years of experience in Quality Assurance or Quality Engineering role - A 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 - Experience with aseptic processing and media fill programs - Actively participate in process improvement - Strong Technical Writing skills - A working knowledge of US FDA, EU, and JP GMP regulations - Up to 50% travel (international and domestic) Preferred Qualifications - Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, medical devices, and combination products - Validation and facility qualification - Previous experience in regulatory inspections - Process start up and clinical trial material manufacturing - Experience performing Technology and Product transfers - Continuous Process Validation - Knowledge of software validation practices and data integrity initiatives Life as a Unitherian At United Therapeutics, youll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
  • 1
  • Negotiable
  • None
  • None
  • Re-159540
  • Permanent
  • 3

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