SUMMARY: US 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, from the upstream capturing the patient journey to the integration process as well as managing Quality Compliance of IT Systems relevant for GxP regulations. Proven end-to-end CSV experience, including planning, execution, documentation, and remediation. As a member of the Quality organization, an additional requirement is to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and USWM's validation practices and procedures. Familiarity with regulatory requirements around audit trails and access control is a plus.
DUTIES AND RESPONSIBILITIES: The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.
- 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.
QUALIFICATIONS: 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.
Desirable- 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.
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL DEMANDS:- Frequently required to stand
- Frequently required to walk.
- Frequently required to sit.
- Frequently required to talk or hear.
- Occasionally required to lift light weights (less than 25 pounds)
- Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
WORK ENVIRONMENT: - The noise level in the work environment usually is quiet.
- Aseptic Gowning is a requirement when executing validation work on the floor.
