Quality Assurance Validation Engineer

Duties and Responsibilities

• Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
• Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
• Supports the qualification/validation effort driven by the MSAT group, including qualification of OSD systems, process validation, and cleaning validation
• Provides support during clients and regulatory audits
• Other related duties as assigned

Required Skills and Abilities

• Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
• Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
• Hands-on experience with a minimum of two of the following: qualification of facilities, utilities, equipment and/or cleaning or process validation
• Experience performing cleaning and/or process validation is preferred 
• Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team 
• Experience performing equipment qualification for OSD systems is required
• Strong time-management skills and the ability to organize and coordinate multiple projects at a time
• Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

• Bachelor’s degree in science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
• Minimum of three years of experience performing qualifications and/or validations

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer
• Prolonged periods of mobility between offices and campus buildings