Senior Automation Engineer - DeltaV

---

Job description

Our client in Lexington, MA has a Direct Hire (non-contract) opening for a Senior Automation Engineer with extensive DeltaV experience.

This role is onsite in Lexington, MA

Duties:
* Will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities.
* Will be the primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of automation systems for cGMP production facilities.
* Provide solutions to complex reliability and operational problems.
* Periodically on-call to support 24/7 production schedule.
* Own and ensure timely closure of equipment related quality systems.
* Subject matter expert for the automation system.
* Own and maintain the design and specifications for equipment and instrumentation.
* Develop automation related SOPs.
* Serve as subject matter expert for quality systems associated with automation systems.
* Evaluate new technologies for their application within a licensed GMP manufacturing facility.
* Maintain control system - system & application backups, virus protection, operating system patches, etc.
* Assist in establishing preventative maintenance requirements and maintaining spare parts support system.
* Specify and document. requirements.
* Implement requirements following internal engineering standard practices.
* Deliver automation design documentation.
* Program, configure, and integrate new equipment into an existing PAS.
* Develop, review, and approve engineering standard practices through collaboration with partner departments - Validation, Metrology, Facilities, Process Engineering, etc.
* Ensure standards are followed and there is cross-site consistency for both in-house and contractor supported changes.
* Develop commissioning test plans for automation changes.
* Provide budgetary and schedule estimates for the automation requirements of projects related to new and existing process equipment and control systems.
* Communicate project requirements to vendors to obtain proposals for hardware and software changes.
* Provide project team with automation requirements.
* Provide control system hardware and instrumentation requirements.
* Develop automation project documentation.
* Support process and facilities engineers in equipment commissioning.
* Pre/Post approve control system validation protocols.
* Troubleshoot and remediate exceptions found during validation.
* Assist process engineers in troubleshooting and remediation of failures.
* Assist in releasing control system for operation.
* Own and manages business and quality systems related to projects.
* Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols).
* Implements automation changes as specified in requirements documents.
* Use project management skills to schedule, track progress, and make adjustments.

Required:
* Bachelor's degree in Engineering or Computer Science with appropriate industrial controls experience.
* Minimum of 6 years experience with Distributed Control Systems and performing instrumentation configuration, programming, and design in a cGMP environment.
* DeltaV (hardware troubleshooting, batch programming including phases, operation, and unit procedure.
* Fieldbus and Profibus.
* ISA-88 (standards and terminology for batch control.

Plusses:
* VMWare and VRTX.
* OSI PI.
* Familiarity with process systems and continuous processes.
* Maintenance of Site Master Equipment History Files.
* Rockwell Automation FactorkTalk AssetCentre.
* Knowledge of industrial panel design including panel drawings and electrical schematics.

Other:
* Strong understanding of Data Integrity (per FDA and EMA).
* Effective verbal and written communication skills.
* Ability to effectively manage the automation lifecycle of controls components.
* Ability to effectively document and specify control specifications; both new from the ground up, and changes to existing systems.
* Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures.
* Adherence to domestic and international GMP regulations.
* Proficiency with Microsoft products; ability to learn additional software applications, as the need arises - TrackWise, Kneat, and Maximo experience a plus.

Other job requirements:
* Position is based out of the Lexington, MA facility.
* Ability to work a hybrid schedule - mix of remote and onsite activities.
* Expected to carry phone device for on-call 24 hour support as required.
* Travel is currently limited to vendor visits including FAT's and external commissioning. Travel may include international travel.
* Travel should not exceed 20%.

- provided by Dice