US WorldMeds · 15 hours ago
Quality Engineering Specialist
Louisville, KY
Full-time
Onsite
Senior Level
$87K/yr - $107K/yr
5+ years expUS WorldMeds is seeking a Quality Engineering Specialist to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations. The Specialist assists with defining qualification & validation strategies and ensures the necessary documents are generated appropriately.
Health CarePharmaceutical
Responsibilities
Responsible for QA review and approval of all validation records and documentation (i.e. process validation, computer system validation, and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports)
Assist in the monitoring of quarterly reports, periodic reviews and/or revalidation of equipment and processes
Review and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments
Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use
Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner
Collaborate on the Aseptic Process Validation strategies, assessments and protocols to ensure the Navy Yard manufacturing facility remains compliant
Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation
Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors
Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Engineering SME
Ensure that work is performed in accordance with applicable regulations, cGMPs, industry guidelines and practices, and Adaptimmune policies and procedures
Participate in efforts to identify opportunities for and to implement continuous improvement and optimization of practices related to validation
Qualification
Required
Bachelor's Degree in Science or related technical field
Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries
Must demonstrate understanding of cGMP's, industry and regulatory guidance, and multinational biopharmaceutical/cell therapy regulations
Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required
Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11
Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA
Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks
Must possess strong verbal/written communication skills and ability to influence at all levels
Experience utilizing quality systems to support Quality Engineering activities (Document management, Training, Deviation management, Change Control management, and CAPA)
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
Deep knowledge of facility/clean room design, process, equipment, automation, and validation
Ability to think strategically and to translate strategy into actions
Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment
Ability to provide clear direction to team members in a highly dynamic environment
Candidate must be proficient in Microsoft Word, Excel, PowerPoint
Preferred
Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, Temp Tale), Building Management systems, Document Control Software
Experience with leading the start-up, validation, and licensure of manufacturing facilities
Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation)
Experience working with cell and gene therapies or biologics products
Experience working with external parties and/or leading cross-functional teams
Company
US WorldMeds
US WorldMeds is a closely-held, Kentucky-based specialty pharmaceutical company. Our mission is to develop, license and commercialize
51-200 employees
H1B Sponsorship
US WorldMeds has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (6)
Funding
Current Stage
Growth StageTotal Funding
$15MKey Investors
National Institute on Drug Abuse (NIDA)
2016-07-01Series Unknown
2013-06-18Grant· $15M
2006-11-13Seed
Leadership Team
H Lee Warren
Chief Operating Officer
Recent News
2025-11-04
Genetic Engineering News
2025-10-28
Company data provided by crunchbase