ESSENTIAL FUNCTIONS
• Interface with Environmental Monitoring, Microbiology, Manufacturing, Quality, Validation, Engineering, and end user groups to provide technical guidance.
• Support implementation of disinfection, facility qualification and media fill/process simulation programs
• Design qualification approaches, provide the scientific rationale and acceptance criteria, generate protocols and assist other department members in conducting industry and regulatory research including research into industry standards/FDA guidelines.
• Operate instrumentation, execute studies, and perform validation activities, including collection of samples, resolution of technical issues. In coordination with affected department management, schedule equipment times, prepare equipment and assure that study is completed according to approved validation protocols and as scheduled.
• Write protocol summaries, reports, and technical reports. Manage and lead project teams, prepare project schedules, coordinate the execution of studies and provide presentations to project stakeholders. Update department management on timelines.
• Perform complex data analysis (including statistical probability) and prepare written reports/summaries from technical studies.
• Cross check and verify validation data prepared by others during the regular peer review process.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Support microbial aspects of continual process verification and prepare reports.
• Conduct training for internal customers.
• Write, review and revise department applicable SOPs.
• Participate and defend qualification approaches in regulatory audits.
• Process change controls, assess impact to product quality and support qualification non-conformance investigations.
• Perform other duties as assigned

EDUCATION/EXPERIENCE REQUIREMENTS
• Requires a Bachelor’s degree in Microbiology, Science or Engineering from an accredited college or university with a minimum of 6 years related experience, with at least 2 years validation experience in a pharmaceutical or related industry.
• An equivalent combination of education, experience and training may substitute.

Qualifications
Attributes
Computer/Software Skills
Requires proficiency in basic MS Word, Outlook, Excel
Compliance Knowledge
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
General Competencies
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Written Communication
Requires ability to interpret / write general business documentS
Problem Solving
Requires ability to solve routine problems
Level of Supervision
Requires direct supervision
Impact of decisions
Impacts one department