Associate Specialist, Validation
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Associate Specialist, Validation will be responsible for supporting the programs and activities related to the lifecycle of validated instrumentation, equipment, and systems. This includes assisting with 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 as assigned
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)
- 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
- Accountable for the scheduling and coordination of validation, calibration and maintenance activities required for cGXP instruments, equipment, and systems
- Assist the Validation Manager in projects associated with validation and calibration responsibilities
- Author validation protocols, and reports; review and approve protocols and reports developed by validation service providers and equipment vendors
- Oversee validation and calibration activities performed by contract service providers
- Assist with executing IOQs and PQs of instrumentation, equipment, and systems
- Assist with writing, reviewing, and executing User Requirements Specifications 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
- Schedules and coordinates service providers visits
- Escorts service vendors when necessary
- Maintains Equipment History Files
- Compiles VCM departmental metrics on a monthly basis or when necessary
- Maintains other miscellaneous departmental files
- Represents VCM at meetings when directed
Minimum Education, Experience and Skills
- Bachelor’s Degree in science or engineering from an accredited university or college, or the equivalent education and experience
- 2-4 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.)
- 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
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.