Automation Validation Lead

Emvia Inc; Andover (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Emvia Inc is looking for an Automation Validation Lead based in Andover, MA. This role involves overseeing automation testing and ensuring the successful validation of all automation systems. The ideal candidate will have a strong background in cGMP environments and will work closely with Engineers and System Integration contractors.

The candidate should also have experience with Emerson Controllers, excellent communication skills, and be able to finalize the Automation Validation Plan effectively.

Qualifications

• 7 years of relevant automation validation experience.
• Strong background working in cGMP environments.
• Excellent communication skills.
• Experience with Emerson Controllers and Emerson DeltaV Software.
• Familiarity with communication methods/protocols such as Ethernet and Profibus.

Responsibilities

• Finalize the Automation Validation Plan.
• Work with Engineers and System Integration contractors to complete validation deliverables.
• Draft and approve automation design and testing documents.

Skills

Automation validation experience

cGMP environments

Communication skills

Emerson Controllers

Allen Bradley PLCs

GEs Proficy FIX

Windows operating systems

Job description

Interview mode – local or regional candidates preferred. May be open to Skype for an excellent candidate.

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. The Automation Validation Lead will report to the Automation Lead and additionally take direction from the Projects 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
• Strong background working in cGMP environments
• Excellent communication skills
• Experience with Emerson Controllers and Emerson DeltaV Software is required
• Experience with Allen Bradley PLCs and I/O
• Experience with GEs Proficy FIX, OSISofts OSIPi or similar Historian software Reporting software, InfoBatch is preferred
• Familiarity with communication methods/protocols: Ethernet, Profibus, OPC
• Familiarity with computer system software and hardware: Windows operating systems, Windows Terminal Services/Remote Desktop, VMWare, Dell VRTX (familiarity is a plus)
• Limited local travel to software Factory Acceptance Tests (FATs) may be required
• Work location: Andover, MA
• Over time may be required during peak times but the expectation is that the workweek will typically be a standard 40‑hour work week

Additional Information

All information will be kept confidential according to EEO guidelines.