Job Description

Job Description

This role is a based in Indianapolis, IN and they are well-resourced to support a full relocation.

About the Role and the Organization

This role is part of a transformative effort to launch a next-generation facility that combines drug development and advanced manufacturing within a single site. The Associate Director – Automation Engineering Control System Validation & Analytics will lead a team of engineers responsible for ensuring compliant, validated control systems and developing site-wide data analytics capabilities. This position will play a central role in shaping validation strategies, system integration, and data governance as the facility ramps up to full GMP operations. The work environment is dynamic and collaborative, requiring adaptability, creativity, and leadership throughout the project and startup phases (2025–2028).

Job Responsibilities

• Lead and develop a team of engineers focused on computerized system validation (CSV), data analytics, and automation compliance across manufacturing systems.
• Oversee development and execution of validation plans, SOPs, audit readiness activities, and CSV documentation for control systems and site platforms.
• Serve as subject matter expert and system owner for validation tools (e.g., Kneat, ALM, Valgenesis) and ensure alignment with regulatory standards and industry frameworks (e.g., GAMP, 21 CFR Part 11).
• Build and manage the site's data analytics capability to support metrics, performance visualization, and strategic insights.
• Support capital projects, new product introductions, and ensure validated state of all control systems including DCS, SCADA, MES, QMS, BMS, and data historians.

Job Requirements

• Bachelor’s degree in Engineering with expertise in Computerized System Validation and Data Analytics, ideally within GMP manufacturing environments.
• At least 12 years of experience in biopharmaceutical engineering, manufacturing, or operations.
• Strong knowledge of regulatory compliance, computer system validation principles, and data integrity requirements.
• Hands-on experience with automation and data systems such as DCS, SCADA, MES, LIMS, QMS, OSI PI, Power BI, and validation tools.
• Proven ability to lead technical teams, influence stakeholders, and represent automation functions during audits and organizational planning.

Contact

If you're interested in learning more, please reach out here or at amit.uma@meetlifesciences.com.

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