Quality Assurance Validation Engineer

Duties and Responsibilities

• Generates and/or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents
• Supports validation lifecycle activities such as, but not limited to, change management, periodic reviews, and re-qualification to ensure that qualified systems remain in their validated state
• Makes compliance decisions to support clinical and commercial operations
• Mentors colleagues on the reasons or justifications of the requirements and practices
• Drives process improvement initiatives
• Provides support during clients and regulatory audits
• Performs other related duties as assigned
• Responsibilities may increase in scope to align with company initiatives

Required Skills and Abilities

• Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, 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 the qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)
• 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
• Strong time-management skills and the ability to organize and coordinate multiple projects at a time
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
• Ability to prioritize tasks and to keep leadership apprised of performance to timelines
• Accepts feedback from a variety of sources and constructively manages conflict
• Experience in Oral Solid Dose operations and spray drying is preferable
• 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 a science, engineering, or related field
• Minimum of 4 years required within pharmaceutical industry, with preference given to those with 5-10 years of experience
• Minimum of 4 years of experience performing qualifications and/or validations is required 

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer
• Prolonged periods of mobility between offices and campus buildings
• Adheres to consistent and predictable in-person attendance