Validation Specialist

NOTICE: Pursuant to 20 C.F.R. 656.10(d), this notice is being provided as a result of the filing of an application for permanent alien labor certification for the following job opportunity:

JOB TITLE &

Employer Name: Validation Specialist for Harvard Bioscience, Inc.

LOCATION: 119-14th Street NW., Suite 100, St. Paul, Minnesota 55112.

JOB DUTIES: Develop and implement validation documentation that include Standard Operating Procedures, Master Validation Documents, and Qualification Documentation for 2 proprietary software applications. Perform risk assessments for DSI software systems against regulations. Assist with internal and external audits to maintain compliance. Author, execute, and/or review Validation documents such as: Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling. Support the development of new processes and troubleshoot existing ones. Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines. Ensure software validation procedures and guidelines are maintained and kept current with regulatory guidelines. Excellent communication, organizational skills, and ability to work closely with internal and external customers. Must possess excellent problem-solving skills. Highly skilled and proficient with Microsoft Word, Microsoft Excel, Microsoft Outlook, and Windows Operating Systems. Must be able to learn and become proficient with additional specialized computer software programs. Eligible for telecommuting from home within a reasonable commuting distance from St. Paul, MN, will require physical presence at worksite in St. Paul, MN at least several days a week.

REQUIREMENTS : Bachelor's Degree or foreign equivalent in biomedical engineering, biological science, or closely related medical/scientific field and 2 years of experience as a Process Engineer, Validation Engineer, Biomedical Engineer in a regulated environment (GLP or GMP) using good documentation practices.

Experience must include two (2) Years of experience in all of the below:

- Development and implementation of validation documentation, including Standard Operating Procedures, Master Validation Documents, and Qualification Documentation for pre-clinical software applications or manufacturing.

- Experience with conducting risk assessments for pre-clinical or clinical or manufacturing proprietary hardware or software applications and software systems against regulations, including Good Laboratory Practices ("GLP"), that includes 21 CFR Part 11 and Part 58, or Good Manufacturing Practices ("GMP").

- Experience with internal and external audits to maintain compliance, including the use of a Quality Management System (QMS).

- Authoring documentation, execution, and review Validation documents, including Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Calculations, Formulation Evaluations, and Deviation Handling.

- Experience with scheduling and execution of validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines, including GLP or GMP.

- Experience with maintenance and assurance of software or hardware or manufacturing validation procedures, including continual changes and progression with current regulatory guidelines.

- Experience with Microsoft Word, Microsoft Excel, Microsoft Outlook, and Windows Operating Systems.

Travel is required to customer sites once or twice per year globally.