Sr. Validation Specialist
Proclinical is currently recruiting for a Senior Validation Specialist with a global surgical instrument manufacturer located in Allentown, PA. As the Senior Validation Specialist, you will interpret and understand relevant laws and standards and provides guidance to Operations, Development, and Quality staff to provide instruction, advice, and enforcement of GMP/GTP compliance.
- Manage, execute, and responsible for the Validation Master Plan (VMP).
- Review, author, and execute IQ/OQ/PQ on all AB GMP equipment (controlled temperature units (CTUs), laboratory instruments, computerized systems, processes, and facility equipment) in compliance with the AB VMP.
- Support, document, and comply with the AB Change Management process as the validation/qualification subject matter expert.
- Conduct thermal validation testing using thermocouple sensors and data collection instruments (Kaye Valprobe, AVS) on equipment including GMP controlled temperature units (CTUs).
- Execute and manage risk assessment, planning, and execution/mitigation activities to ensure the quality of equipment, systems, processes used in the manufacture of product are maintained throughout their lifecycles.
- Manage suppliers/contractors/budget for the execution and reporting of GMP functions (installation, commissioning, validation), as required.
- Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations.
- Support, develop, author, and approve Computer System Validation (CSV) documentation including requirement/design specification support, creation of testing documentation and validation reports in compliance with the AB CSV and SDLC process.
- Conducts system administration activities for computerized systems (e.g. user management, periodic maintenance, updates, etc.), as-required.
- Participates in cross-functional design, development, improvement, and investigative activities (root cause analysis) especially in support of validation and qualification activity.
- Executes and manages periodic assessment and qualifications for controlled temperature units (CTUs), lab instruments, computerized systems, processes, and facilities.
- Capable of applying and leading teams in the use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities.
- Creates, prepares, and presents Quality System Management Review data for validation / qualification metrics.
- Support and actively participates in third party audit and regulatory inspection activities (PAI).
- Author, review, and approval of CMC / Biological Licensing Application (BLA) documentation for submission to the FDA.
- The ability to gown and mask for performance or observation of aseptic processing in a clean room environment is required.
- This position may be exposed to potentially contaminated instruments and blood or other bodily fluids.
- In compliance with Occupational Safety and Health Administration (OSHA) regulations, AB will
Skills and Requirements:
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
- Must embody the Company's Vision, Mission and Values.
- Other quality related duties may be assigned.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.