US WorldMeds · 2 hours ago
Computer System Quality Validation Engineer
Philadelphia, PA, US
Full-time
Onsite
Senior Level
$108K/yr - $132K/yr
5+ years expUS WorldMeds is seeking a Computer System Validation Engineer to play a pivotal part in ensuring the compliance and efficiency of computerized systems involved in several stages of the Validation-cycle. The role involves providing quality assurance support for system development life cycle deliverables, leading validation teams, and ensuring compliance with GxP regulations.
Health CarePharmaceutical
Responsibilities
Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of systems and applications to support GxP operations
Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing
Lead validation teams to a better understanding of validation best practices and applying quality principles
Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations
Collaborate with cross-functional teams on the integration of data systems and implementation of audit trails, access controls, and data integrity strategies
Identifies and resolves issues interfering with execution of deliverables
Enforces Good Documentation Practices and ensures that SDLC deliverables are properly archived and available for internal and external regulatory inspection
Collab with Supplier Quality Management to ensure vendor compliance to regulations and standards before introducing instruments or applications into the lab and production environment
Attend meetings as quality representative and capture meeting minutes, escalating items as appropriate
Liaise with key personnel within project teams to ensure project remains on target for key milestones
Responsible for QA review and approval of all validation records and documentation (i.e. computer system validation and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports)
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
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
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 working with automation and/or computerized system validations in the biotechnology or pharmaceutical industries
Must demonstrate understanding of cGMP's, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations
Prior experience leading or managing projects beneficial
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 CSV/CSA activities (Document management, Training, Deviation management, Change Control management, and CAPA)
Proficient skills dealing with and understanding typical laboratory, facilities and manufacturing equipment for cell therapy manufacturing 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, TempTale), Building Management systems, Document Control Software, Sepax/SepaxNet, Wave Bioreactors/Unicorn Software, MODA, Pas-X, StarLIMS
Experience with leading the start-up, validation, and licensure of manufacturing facilities
Strong knowledge and direct experience with systems and applications required for aseptic manufacturing
Experience working with cell and gene therapies or biologics products
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