Validation Engineer

The employee will work as part of cross-functional team providing quality oversight, review, execution, and approval for validation deliverables to ensure the process and products meet appropriate regulatory agency validation requirements, internal company standards, and cGMP. This position will typically focus on disciplines related to requalification of equipment, process, control systems, and computer system validations.

Primary Responsibilities:

• Leads preparation, execution, data collection, and authoring validation reports under direct supervision
• Prepares validation protocols, reports, test equipment, and evaluates validation test results for data integrity and accuracy
• Authors and prepares summary reports to determine pass/fail results
• Develops programs and maintain standard operating procedures (SOP)
• Support document management via Learning Management System (LMS), GxP Training, and GDRS
• Demonstrates effective communication regarding assigned study activities and project deliverables

Minimum Qualifications:

• Bachelor of Science in Engineering, Biotechnology, or Science discipline (e.g. Chemistry, Biology, Microbiology, etc.)
• 0-3 years’ experience in the Pharmaceutical/Biotech Industry
• 0-1 year experience in a quality or validation role in pharmaceutical manufacturing