Aveva PI Engineer

Senior Aveva PI System & Validation Consultant

We are seeking a Senior Aveva PI System & Validation Consultant to lead the technical ownership, validation oversight, and future-proofing of an on-prem Aveva PI implementation at its manufacturing site. This role is critical to ensuring the system is compliant, scalable, governed, and aligned with GMP, ISA-95, and global manufacturing digitalization standards. The consultant will step into a partially implemented PI environment and act as the hands-on technical owner, responsible for gap analysis, governance enforcement, AF framework design, validation alignment, and long-term architectural readiness for multi-site CDMO operations.

Essential Job Duties & Responsibilities

PI System Leadership & Architecture

Lead the implementation, stabilization, and governance of the Aveva PI System. Perform a comprehensive gap analysis across architecture, namespace, AF readiness, performance, and validation. Design and implement an ISA-95-aligned AF framework, including hierarchies, templates, and metadata. Establish and enforce global namespace standards, naming conventions, metadata structures, and APR key management. Ensure clean incorporation of legacy SQL-based tag data into the PI namespace architecture. Validate consistency, performance, and scalability across Dev / Val / Prod environments. Support and oversee PI-to-PI federation between the system and a newly peered PI instance. Configure and maintain PI system health monitoring (disk utilization, CPU usage, interfaces, clusters, and HA components).

Validation & Compliance

Provide expert oversight of validation deliverables across URS, DDS, IQ, OQ, and PQ. Support and approve validation documentation in compliance with GMP, GxP, and CSV standards. Ensure PI configurations meet regulatory expectations for data integrity, traceability, and audit readiness. Partner with QA to proactively identify and mitigate validation and compliance risks.

Standards, Governance & Best Practices

Develop PI System Administration and User SOPs. Define and implement best practices for PI in a regulated CDMO environment. Establish clear governance models for decision-making, change control, and long-term system sustainability. Champion industry standards (ISA-95, data governance) across the project lifecycle. Review, confirm, and document technical and architectural decisions for traceability.

Collaboration & Project Execution

Collaborate closely with IT, QA, Engineering, and business stakeholders to gather requirements and align priorities. Work with the Project Manager to manage schedules, deliverables, dependencies, and risks. Drive accountability across milestones, deliverables, and operational readiness. Communicate risks early, propose mitigation strategies, and course-correct proactively. Ensure alignment with global IT strategies and manufacturing digitalization goals.

Training & Enablement

Provide training and guidance to site teams and users on Aveva PI usage, administration, and best practices. Enable internal teams to operate, maintain, and scale the PI framework post-engagement.

Leadership Skills & Attributes

Demonstrated technical leadership and innovation in PI system design. Strong sense of ownership and accountability for system quality and compliance. Proactive risk identification and mitigation mindset. Ability to operate effectively in regulated, high-pressure environments. Excellent collaboration, communication, and stakeholder engagement skills. Trusted business partner who balances