Automation Validation Lead

Mindlance; Andover (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading technology and engineering firm is seeking an Automation Validation Lead to oversee automation testing within a cGMP environment. The role involves finalizing the Automation Validation Plan and providing guidance on validation best practices. The ideal candidate will have at least 7 years of relevant experience and strong communication skills. Familiarity with Emerson Controllers, DeltaV Software, and various hardware/software is essential. This position may require limited local travel to software Factory Acceptance Tests.

Qualifications

• 7 years of relevant automation validation experience.
• Strong background in cGMP environments.
• Experience drafting and reviewing automation design and testing documents.

Responsibilities

• Oversee automation testing to ensure successful validation of automation systems.
• Finalize the Automation Validation Plan.
• Guidance on validation best practices.

Skills

Automation validation experience

Strong communication skills

Experience with Emerson Controllers

Knowledge of Ethernet

Tools

Emerson DeltaV Software

Allen Bradley PLCs

OSISoft’s OSIPi

InfoBatch Reporting Software

VMWare

Job description

Job Description

The Automation Validation Lead is responsible for overseeing all automation testing (leveraged software Factory Acceptance Tests, Commissioning and Validation) to ensure successful validation of all automation systems in the ACMF/Building E at the Site.

Reporting:

The Automation Validation Lead will report to the Automation Lead and additionally take direction from the Project’s Validation Lead. The Automation Validation Lead will be an active member of the overall project team working with the team, Engineer of Record and Construction Manager.

Key Responsibilities:

• Finalize the Automation Validation Plan
• Work with a team of engineers and System Integration (SI) contractors to complete all validation deliverables related to the Delta-V Manufacturing Control System (MCS) and Qualified Utilities Network (QUN)
• Give guidance on validation best practices for automation hardware, software and computer systems.
• Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance
• Draft, review or approve automation design and testing documents for all phases of testing (sFAT, Commissioning, Validation)
• Drive deviation resolution for all testing

Requirements:

• 7 years of relevant automation validation experience
• The candidate must have a strong background working in cGMP environments.
• The candidate must have excellent communication skills.
• Experience with Emerson Controllers and Emerson DeltaV Software is required.

The ideal candidate would have experience with the following hardware:

• Allen Bradley PLCs and I/O

The ideal candidate would have experience with the following software:

• OSISoft’s OSIPi or similar Historian software
• Reporting software, InfoBatch is preferred

The ideal candidate should be familiar with the following communication methods/protocols:

• Ethernet

The ideal candidate should be familiar with the following computer system software and hardware:

• Windows operating systems
• Windows Terminal Services/Remote Desktop
• VMWare
• Dell VRTX familiarity is a plus

Countries / Regions of Expected Travel: Limited local travel to software Factory Acceptance Tests (FATs) may be required

Additional Information

All your information will be kept confidential according to EEO guidelines.