Responsible for developing and executing Validation/Qualification Protocols and summary reports. to ensure compliance with regulatory agency requirements, internal company standards and current industry practices.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
• Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, utilities (as applicable) and other related systems in an FDA regulated environment
• Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, and manufacturing processes in accordance with predefined test protocols.
• Resolve all deviations and non-conformances reported during validation/qualification.
• Analyze validation results and compile data into summary reports for initial qualifications and re-qualifications.
• Coordinate testing schedule with impacted area managers and quality control based on project needs.
• Provide input to technical composition of standard operating procedures.
• Create department standard operating procedures, review and revise them as applicable.
• Investigate and troubleshoot validation problems.
• Participate in equipment failure investigations, corrective/preventive actions and equipment release.
• Contribute to the successful completion of project milestones and crucial technical tasks.
• Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
• Review and approve validation documentation.
• Assess the impact of changes to validated systems and write protocols to achieve and maintain cGMP compliance.
• Review of change control, SOP's, calibration, preventative and corrective maintenance documentation for equipment/system to assure that all remain in a validated state (Periodic review of equipment/system)
• Perform other duties as needed.
Work Experience Requirements:
• Bachelor's degree, preferably in Engineering.
• Preferred three (3) to five (5) years in a CGMP-related industry with at least one (1) to two (2) years in validation of equipment, utility, process and/or software validation in a GMP regulated environment.
• Code of Federal Regulations and cGMP's relating to the field of validation.
• In depth knowledge of FDA guide line for Equipment, Facility. Laboratory instrument, Process Validation, Cleaning Validation & Computer System Validation
• Demonstrated understanding of process and mechanical engineering.
• Ability to establish clear priorities quickly.
• Ability to work effectively under pressure, handle multiple projects and meet deadlines.
• Excellent technical writing skills
• Strong communication skills; able to interface with all levels of the organization.
• PC literate, word processing and spreadsheet software
• Basic math and statistical skills
• Must be people oriented and a team player.
• Experience with Microsoft office including excel, PowerPoint, word, project and Visio.
• Familiarity with control chambers mapping and re-mapping qualification process.
• Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
• Experience with writing validation protocols and final reports and managing validation projects.
• Ability to read/interpret engineering drawings and design documents.
• Knowledge of risk management tools and techniques
• Mathematical and reasoning ability
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines and handle multiple projects.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-75 pounds.
• Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment.
• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
• Individual's primary workstation is located in the office area, where the noise level is low.
• The employee will be present on the manufacturing floor where the noise level is low to moderate.
• The employee will also be present in the Formulation and Analytical Laboratories where the noise level is generally low with a few exceptions.
• Occasionally the employee will be expected to visit the technical areas either behind or above the process areas where the noise levels are much higher, the construction site and pilot manufacturing areas....cont.