Aveva PI Engineer

Senior Aveva PI System & Validation Consultant

• Remote (US-based) | Must support US time zones
• Contract | Estimated duration: January - July (with potential extension)

Overview

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 technical rigor with operational needs.

Qualifications

Required

• 12+ years of experience designing and implementing Aveva PI Systems in GMP-regulated manufacturing environments (Pharma/CDMO strongly preferred).
• Expert-level knowledge of Aveva PI System and PI AF.
• Hands-on experience with PI Edge Data Store and Aveva Edge.
• Deep understanding of GMP, GxP, and CSV validation lifecycles (URS DDS IQ/OQ/PQ).
• Proven experience enforcing namespace standards and metadata governance at scale.
• Strong project execution and cross-functional collaboration skills.

Preferred

• Experience supporting integrations or architectural readiness for DeltaV, Batch, BMS, SCADA, and manufacturing systems.
• Demonstrated success designing reusable, multi-site PI frameworks aligned to ISA-95.
• Background in scaling PI environments from small deployments to enterprise/global usage.

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