Plans, communicates, and leads scientifically sound strategies for large scale, multi-facetted validation projects in a cGMP environment. Works closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and R&D to achieve project deliverables. Able to independently design, schedule, and execute qualification/validation experiments which demonstrate compliance with regulatory requirements, product license restrictions, and industry standards. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Represents the validation department on cross-functional and/or global projectteams.
Main Responsibilities and Accountabilities
1. Responsible for achieving department objectives/schedules while working across multiple departments.
2. Plans, communicates and leads scientifically sound validation strategies for small to large scale multi-facetted validation projects including timelines, cost estimates, and assigned resources (validation contractors).
3. Leads assigned resources (validation contractors) to achieve project deliverables, as required.
4. Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to validation study execution/testing requirements and status of assigned execution activities.
5. Prepares validation project plans, protocols, and test equipment for execution. Collects and evaluates validation test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies.
6. Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria.
7. Able to recognize and trouble shoots problems associated with validation studies, equipment, and procedures.
8. Assists in the preparation of proposals and bid packages to secure validation contractor services.
9. May serve as Subject Matter Expert (SME) for review of Validation and Engineering Qualification protocols and reports for adherence to cGMPs, good documentation practices, and general quality oversight.
10. Assists in review of Deviations, Change Controls, Material Change Controls, Document Change Controls as an SME for Validation.
11. Provides technical support/training to Validation department personnel and other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed.
12. Researches governmental regulatory requirements and industry guidance on assigned projects.
13. Assists the in development of validation programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements.
14. Supports the facility in internal and external inspections.
15. Other tasks as required by Departmental Management.
Education: BS in Engineering, Physical or Biological Science with 5+ years validation experience or Associates Degree with 8+ years related validation experience. Proven demonstration to perform in the role may also be considered.
Experience: Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing. Experience in project management, problem solving analytical/conceptual thinking, and time management. Developing skills in interpersonal communication, delegation, and decision making Direct interaction with FDA desirable.
Able to enter into confined spaces (i.e. process tanks), as required. Able to wear scrubs and meet cGMP gowning requirements to work in manufacturing environments.