Warehouse Automation Area Lead
LVI Associates · Hendersonville, TN · 1 wk ago
EngineeringFull-time
About the role
We are seeking an experienced Warehouse Automation Area Lead to provide technical leadership for the automation and control systems associated with a large-scale warehouse project within a regulated manufacturing environment. This individual will ensure the automation solution aligns with overall program standards, user requirements, and established automation strategies. The successful candidate will work closely with cross-functional stakeholders including Automation Project Managers, Technical Leads, Area Leads, Process Engineering teams, Manufacturing Science representatives, Quality personnel, Operations, and external system integration partners to deliver a robust and compliant automation solution.
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.
- Coordinate the collection and review of 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.
- Assist 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.
Requirements
- 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.
- Proven experience delivering automation solutions on large-scale pharmaceutical capital projects or expansion programs.
- At least 5 years of hands-on experience with Allen-Bradley PLC platforms.
- 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.
Preferred Qualifications
- Experience supporting warehouse control systems within pharmaceutical, biotechnology, or highly regulated manufacturing facilities.
- Familiarity with large-scale automation deployments involving integration of skidded equipment, process controls, and validation activities.
- Strong knowledge of automation lifecycle deliverables including URS, FRS, FDS, control strategies, commissioning, qualification, and validation documentation.