Validation Specialist
Employment Type : Full-Time
Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.
JOB SUMMARY
The Validation Specialist will be responsible for supporting the programs and activities related to the lifecycle of validated instrumentation, equipment, and systems. This includes the planning, execution and documentation of all validation and calibration activities, to ensure that all cGxP instruments, equipment and systems are maintained in a validated and calibrated state. This position includes collaboration with both, contract service providers and Emergent personnel, as well as executing hands-on equipment validation and calibration activities
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Participate in managing the life cycle of instrument, equipment and system validations performed at the San Diego site (including, but not limited to, Research and Development, Clinical Immunology, Process Development and Production, Product Development, Analytical Development, Quality Control and Facilities).
- Assist with maintenance and administration of the Asset Management tool(s) used for managing the site’s validations, calibrations, and maintenance activities.
- Perform in-house calibrations as needed.
- Write calibration procedures and other calibration-related documents.
- Assist the Validation Manager in managing the annual budget and spend for the San Diego site’s validation and calibration expenses.
- Assist the Validation Manager in developing, maintaining, and administering the San Diego site’s Validation Policy, Validation Master Plan(s) and all SOPs related to the site’s validation and calibration programs.
- Assist the Validation Manager in projects associated with validation and calibration responsibilities.
- Author validation plans, protocols, and reports; review and approve plans, protocols and reports developed by validation service providers and equipment vendors.
- Oversee validation and calibration activities performed by contract service providers.
- Execute IOQs and PQs of instrumentation, equipment, and systems.
- Assist with writing, reviewing, and executing User Requirements Specifications, Factory Acceptance Tests and Site Acceptance Tests for instruments, equipment, and systems.
- Work closely with Quality, R&D, Process Development, Product Development, and Facilities to investigate and resolve deviations through determining root cause, product impact, and appropriate corrective and preventive actions related to equipment or validated process parameters.
- Assist in providing responses to audit observations and manage audit related CAPA commitments.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s Degree in science or engineering from an accredited university or college, or the equivalent education and experience
- Four (4) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof
- Desirable cGxP validation experience, including lab instrumentation, process equipment, utilities, automation (including BMS), computer systems,
- Proven skill in the use of thermal mapping equipment (e.g., Ellab and Vaisala) in validating temperature-controlled units
- Proven skill in the use of standard calibration tools (e.g., digital multimeters, RPM meters, temperature baths, weights, and measures, etc.)
- Validation experience using in-house developed protocols as well as leveraging vendor-supplied and executed protocols
- Experience with investigations into deviations and determination of impact, root cause, and corrective actions
- Excellent technical writing and verbal communication skills
- Significant experience in authoring protocols, reports, User Requirements Specifications (URSs), procedures, and similar technical documents
- Proficiency in using electronic document management systems (eDMS) and the related workflow management
- Ability to read/interpret engineering drawings and design documents
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions
- Demonstrated ability to manage multiple activities while maintaining a high level of organization
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
- Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals
If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.