Primary Role:
This position is responsible for supporting Analytical Labs (e.g. QC, PAD) including qualification/validation of Environmental Chambers, Software Applications, Analytical Instruments, and Information Technology (IT) Infrastructure Components (e.g. Network Servers and Client Workstations).
General Responsibilities include:
• Generation of Analytical Instrument / Equipment qualification and Lab Computer System validation protocols.
• Field execution of qualification/validation protocols, including troubleshooting of problems by partnering with System Owners, Vendors, and IT.
• Collation of qualification/validation packages and summarization of results in a format ready for external regulatory inspections (e.g. FDA).
• Keeping abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques and literature regarding compliant computer operations. Serving as an information resource.
Responsibilities:
• Develop validation protocols, execute validation studies, perform data analysis, and compile data and results into final reports. Schedule and lead meetings with System Owners, IT, and QA to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol acceptance criteria. Lead or coordinate, as applicable, investigations into failures to meet protocol acceptance criteria. Review and approve validation protocols and reports. (50%)
• Review proposed changes to qualified Analytical Instruments and validated Lab Computer Systems and associated IT infrastructure components and identify the validation requirements necessary to maintain the system’s validation status after execution of the change. (30%)
• Develop and standardize appropriate procedures to be used in qualifying Analytical Instruments / Equipment and validating Lab Computer Systems and associated IT infrastructure components, manage and control validation documentation, and maintain the validation documentation database. (10%)
• Train and oversee Vendor personnel who will be executing Analytical Instrument / Equipment and Lab Computer System Vendor protocols on Shire HGT’s behalf. (10%)
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements:
Education & Experience Requirements:
• Require B.S. w / 3-5 years validation experience or M.S. w / 2-4 years validation experience.
• Preference given to candidates with previous experience in qualifying Analytical Instruments / Equipment and/or validating Lab Computer Systems in the biopharmaceutical or pharmaceutical industries.
Key Skills and Competencies:
This position requires excellent organizational and communication skills, attention to detail, and a thorough knowledge and understanding of FDA and foreign (European and Canadian) validation requirements and expectations.
This position also requires knowledge of GAMP 5 and Risk Management Principles.
The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines.
Complexity and Problem Solving:
The incumbent will be involved in a wide range of complex problems, which require the regular use of ingenuity and creativity, working without appreciable direction, and exercising considerable latitude in determining assignment objectives.
She/he may propose alternative methods and procedures to be used on new assignments.
Completed work is reviewed from both a short term and long term perspective for desired results.
Internal and External Contacts:
This position will have frequent contact with management and outside contract/vendor professionals and will act as the validation lead for projects.
Erroneous decisions or recommendations would typically result in failure to achieve group/dept. objectives and cause significant expenditures of time and money to correct.
While this position has no direct reports, it is expected to provide guidance or oversight to vendor personnel.
Other Requirements:
Travel to other Shire locations and to vendors for audits may be occasionally required.
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