-Part of a team responsible for developing and optimizing the validation program for a gene therapy manufacturing facility making the transition from clinical to commercial.-Responsible for performing updates and revisions to a number of validation documents and standard operating procedures.-Developed risk assessment for site’s critical utility systems, including Process Gases (N2, O2, CO2, and CCA), WFI, DI, and Clean Steam with the aim of developing appropriate sampling programs to support multiple manufacturing suites.-Aided in design and execution of multiple media fill studies on closed isolator filling system.

-Responsible for alignment of validation strategy across manufacturing facilities and validation oversight of critical capital projects for the entire Tissue Technologies division.-Management of a larger team of 13 validation engineers, directly working with several facilities throughout the United States-Continuous training in leadership role and working alongside upper management teamResponsibilities of “Manager” role continued (as listed below)

-Managed global team of validation engineers spread throughout multiple US-based manufacturing facilities-Provided guidance on validation topics across all of Integra, and assisted in the implementation of aligned validation strategy on a global scale-Guided several facilities in remediation efforts, involving management of a team in performing gap assessments, developing and updating quality plans and project schedules, and drafting various quality systems standard operating procedures-Involved in planning and development of validation strategy in multiple site-wide expansion / cleanroom construction projects. Participated in project scoping, drafting of validation master plans, project schedules, and resourcing.-Led team in preparation for, and support in multiple FDA / MDSAP audits at different Integra facilities, in both back-room and front-room capacities.-Provided sterility assurance guidance to multiple facilities, on topics ranging from environmental monitoring, to cleanroom behavior and gowning technique, to best practices for room sanitization

-Generated and executed Installation, Operational, and Performance Qualification technical documents on a variety of process equipment and systems-Worked with cross-functional teams across multiple sites including Manufacturing, Quality Assurance, Sterility Assurance / QC-Micro, Facilities, and Regulatory to support process transfers and large scale validation projects. -Involved in general oversight and advisement to global manufacturing facilities on validation and compliance related topics-Performed internal audits of validated systems and strategies across multiple manufacturing facilities-Carried subject matter expertise in Clean Rooms and Controlled environments to the global level, and designed or executed Environmental Monitoring Performance Qualifications (EMPQs) at cleanrooms across more than 5 manufacturing sites -Developed best practice guide for writing and executing validations to standardize validation practices across manufacturing sites-Managed and coordinated both contract and site-specific resources across multiple manufacturing sites, in support of various capital projects -Assisted in developing validation master plans and standard operating procedures

-Generated and executed various equipment Installation, Operational, and Performance Qualification and commissioning technical documents, including but not limited to autoclaves, incubators, cold rooms, water baths, facilities, sealers, and lyophilizers. -Developed and executed cleaning validation studies on a variety of site processes, including the collection of swab and rinse samples, and visual inspection of cleaned equipment.-Performed comprehensive review and revisions to site process cleaning procedures-Developed Requalification program for routine revalidation of process equipment-Worked with a cross-functional team including Manufacturing, Quality Assurance, QC-Micro, QC-Analytical, Facilities, and Regulatory in support of key manufacturing transfer project at the CMC facility.-Oversaw validation of newly constructed cleanroom in manufacturing facility and associated Clean Steam, WFI, and Clean Compressed Air systems, and ISO 5/7 environments. -Involved in investigation and remediation of multiple complex protocol deviations-Executed temperature mapping studies using wireless (Valprobes) or wired (Kaye 2000 / AVS) data monitoring devices and oversaw the maintenance and use of monitoring equipment-Managed and coordinated contract resources in support of completion of project goals-Served as site Subject Matter Expert (SME) in validation of Utility Systems, Clean Rooms and Controlled Environments, and Temperature Mapping-Assisted in developing validation master plans and standard operating procedures-Maintained aseptic gowning qualification

-Generated and executed various equipment Installation and Operational Qualification and commissioning technical documents, including but not limited to autoclaves, clean steam generators, particle counters, HVAC Systems, facilities, stability chambers, and incubators-Assisted in developing validation master plans and standard operating procedures-Executed temperature mapping studies using wireless (TempTales, Veriteqs) or wired (Kaye) data monitoring devices and oversee the maintenance of monitoring equipment-Performed process validation activities including media-fill simulations and packaging qualifications -Coordinated and participated in validation activities associated with integrated sterile manufacturing line comprised of auto vial washer, depyrogenation tunnel, and automated vial filling line in aseptic filling suite-Maintained aseptic gowning qualification

-Maintained aseptic gowning qualification for entry into and activities within Grade A, B, and C Clean rooms-Facilitated the operation of various sterile filling machines as primary operator within manufacturing suites to produce a wide range of products including ointments, ophthalmics, and small volume parenterals-Participated in numerous media fills acting to qualify the sterile production process of multiple aseptic filling suites-Performed routine cleaning and sanitization of sterile clean rooms using standard cleaning agents (IPA, Vesphene, LPH, SporKlenz)