Master’s degree in Science or Engineering OR
Bachelor’s degree in Science or Engineering AND 2 years of directly related experience OR
Associate’s degree in Science or Engineering AND 6 years of directly related experience.
**Work schedule is weekdays from 8:00 AM to 5:00 PM, but coverage of activities in a non-standard shift may be required based on manufacturing schedule. The selected candidate should be able to support those activities at non-standard shifts.
– Experience in a regulated environment; Biotech, Pharmaceutical, Medical Devices, etc.
– Experience in Process Validation (PV)
– Experience with PV documentation (authoring, data verification, etc.), GMP systems (LIMS, Trackwise, HLEE, Plant Information System, etc.), on the floor execution, etc.
Under general supervision, provides direct technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing, or manufacturing support environment. Able to troubleshoot basic validation issues. Applies basic validation engineering principles to the design and implementation of system or process modifications and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of minor scope and complexity. Provide solutions to a variety of technical validation problems of moderate scope and complexity. Under general supervision will evaluate, select and apply standard validation engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Function as a technical validation expert to equipment or systems regarding troubleshooting operations. Frequently become actively. Involved in daily operations when required to meet schedules or to resolve complex validation problems. Routinely audit the validation status and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with manufacturing, maintenance, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete the validation responsibilities of engineering, and construction projects within schedule and budget constraints. Generate rudimentary project cost estimates and schedules. Prompt and regular attendance to the workplace.. Master’s degree or Bachelor’s degree & 2 years of directly related experience or Associate’s degree & 6 years of directly related experience.
Working knowledge of validation processes and programs. Familiarity with pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply validation engineering to production. Able to develop solutions to routine technical problems of limited scope. Demonstrated skills in the following areas: Problem solving and applied engineering. Basic technical report writing. Verbal communication. Computer Literacy. Comprehensive understanding of validation processes and programs. Demonstrated Skills in the following areas: Basic technical presentations. Personal Organization. Validation Protocol & Report Writing, Dealing with and managing change. Technical (Equipment Specific). Analytical Problem Solving