CAI - Computer Systems Validation Engineer

• Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted • Minimum of 3+ years of experience in computer systems validation • Experience in biotech or pharmaceutical environments preferred over medical device • In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) • Familiarity with S88/S95 batch control standards • Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred • Experience with multiple automation and manufacturing execution systems is highly desirable • Data integrity assessment/remediation experience is a plus • Excellent oral and written communication skills in English • Ability to travel domestically and internationally as required • Willingness to work paid overtime when needed • Must be authorized to work in the U.S. without current or future sponsorship • Critical Competencies • Influence Strategy • Pursues opportunities based on organizational fit and strategy • Identifies high-impact, innovative solutions • Satisfy the Customer • Anticipates and meets client needs • Delivers high-quality solutions and maintains satisfaction • Plan for Success • Aligns business goals with execution plans • Allocates resources and builds risk mitigation strategies • Pursue Execution • Prioritizes effectively and ensures accountability • Proactively addresses challenges • Tailor Communication • Communicates clearly and professionally • Adapts style for technical and non-technical audiences • Build Partnerships • Builds cross-functional networks • Promotes collaboration and stakeholder engagement • Influence Others • Gains support through sound reasoning • Promotes innovation and value • Develop Self and Others • Demonstrates integrity and commitment to growth • Builds effective relationships internally and externally • $75,000 - $106,000 a year • Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.