Warehouse Project Automation Area Lead

Key Responsibilities

• Assume technical ownership of all automation activities within the warehouse project area.
• Define and develop the ISA-88 (S88) software architecture and equipment model structure.
• Create initial Functional Design Specifications (FDS) and collaborate with integration partners to finalize documentation.
• Participate in P&ID reviews, control strategy assessments, and automation design discussions.
• Partner with system integration teams to ensure successful project execution within established timelines and budgets.
• Collaborate with program-level technical teams to ensure consistency with automation standards, philosophies, and best practices.
• Maintain alignment and consistency across automation deliverables, including requirements, functional specifications, control strategies, and related documentation.
• Provide regular updates on project progress, challenges, and technical requirements to automation leadership.
• Review, approve, and contribute to functional requirements and design specifications.
• Support the development of Computer System Validation (CSV) documentation in partnership with system integrators.
• Cook up vendor documentation for skidded equipment to support validation and integration activities.
• Address and resolve technical queries from system integration partners and project stakeholders.
• Identify process control software issues requiring remediation and develop appropriate solutions.
• Aid in the implementation and verification of automation system architecture.
• Manage issue tracking and documentation of defects, enhancements, and corrective actions following software acceptance activities.
• Proactively identify technical risks, assess potential impacts, and develop mitigation strategies.
• Maintain compliance with all required training, quality, and regulatory standards.

Qualifications & Experience

• Bachelor's degree in Engineering or equivalent combination of education and relevant experience.
• Minimum of 8 years of automation experience within the pharmaceutical or life sciences industry, preferably supporting API or bulk manufacturing operations.
• Prior experience supporting warehouse automation or automated material handling systems is highly desirable.
• Strong understanding of GMP environments, regulatory compliance requirements, and Computer System Validation (CSV) methodologies.
• Experience working with system integrators, multidisciplinary project teams, and external vendors.
• Excellent communication and interpersonal skills, with the ability to engage effectively with both technical and non-technical stakeholders.
• Strong organizational, problem-solving, and analytical abilities.
• Demonstrated ability to thrive in collaborative, fast-paced project environments.