Validation Specialist

Harvard Bioscience • New Brighton, MN

11d • Hybrid

About The Position

Harvard Bioscience, Inc. is seeking a Validation Specialist to develop and implement validation documentation for two proprietary software applications. This role involves performing risk assessments for DSI software systems against regulations, assisting with internal and external audits, and authoring, executing, and reviewing various validation documents. The specialist will support the development of new processes and troubleshoot existing ones, ensuring software validation procedures align with current regulatory guidelines. Excellent communication, organizational, and problem-solving skills are essential, as is proficiency with Microsoft Office Suite and Windows Operating Systems. The ability to learn specialized computer software is also required. This position offers eligibility for telecommuting from home within a reasonable commuting distance of St. Paul, MN, but will require physical presence at the St. Paul, MN worksite several days a week.

Requirements

• Bachelor's Degree or foreign equivalent in biomedical engineering, biological science, or closely related medical/scientific field.
• 2 years of experience as a Process Engineer, Validation Engineer, or Biomedical Engineer in a regulated environment (GLP or GMP) using good documentation practices.
• Two (2) years of experience in 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 of 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.
• Excellent communication, organizational skills, and ability to work closely with internal and external customers.
• Must possess excellent problem-solving skills.
• Must be able to learn and become proficient with additional specialized computer software programs.

Responsibilities

• Develop and implement validation documentation, including 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 troubleshooting existing ones.
• Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
• Ensure software validation procedures and guidelines are maintained and kept current with regulatory guidelines.
• Travel to customer sites once or twice per year globally.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level