Senior Instrumentation & Controls Engineer - Biotech - Framingha

Company Name:
POSITION: Senior Instrumentation & Controls Engineer - Biotech - Framingham, MA
SALARY RANGE: Base salary from $116,000 to 125,000 plus bonus
PRIMARY LOCATION: Framingham, Massachusetts
The Engineering department is the subject matter expert for all process and utility equipment for the Framingham Biotech / Pharmaceutical manufacturing site. Engineering is chartered with the task of ensuring the process and utility equipment is operating within its intended design, is maintained at a proper maintenance interval, and that any equipment related failures are fully investigated and robust CAPA are implemented to prevent a recurrence.
REPORTING TO: This Position will report to the Manager Manufacturing Engineering.
From I/O Card to instrumentation, inclusive of transmitter and cabling. Lead resource for instrumentation related issues. Design review for new implementation and legacy systems. Trending of failure rates and deviations to identify bad actors. Process Automation lead liaison between automation and Process / Utilities Engineering. Alarm management service provider determining effective alarm rationalization. Lead for ensuring configuration parameter management on transmitters. Mentor for engineering staff on I&C troubleshooting. Subject matter expert for VFDs, Cabling, and transmitters.
Bachelor degree (BS) in Electrical, Chemical Engineering or related field.
General programming and troubleshooting background with PLCs, DCS, HMI, SCADA
Instrumentation best practice use, issue resolution
Communications experience with OPC, analog, bus, network, etc.
Probe and analytic experience
Knowledge in enclosure / washdown / IS ratings
Arc flash safe work practice training
PREFERRED: Previous experience with Delta V and Rockwell systems
PREFERRED: Demonstrated ability to lead small to moderate scale projects
Knowledge of GAMP 5, ISA and current Good Engineering Practices
5+ years of Biotech and/or Pharma / Medical Device experience
10+ years of I&C experience
Use of Windows / MS Office, MS Project, Outlook, general office productivity software
Ability to work in a matrix environment
MANUFACTURING ENGINEERING: Assist with functional equivalent determination on I&C related items. Design review resource. Controls troubleshooting resource. Interpretation of controls implementation strategy on Change Controls.
COMMISSIONING AND QUALIFICATION: Review C&Q protocols and reports associated with I&C / Automation. Support execution activities or discrepancy investigation / resolution.
METROLOGY: Complete Calibration Parameter Worksheet(CPW) I&C evaluations. Work with Metrology on investigations significant of out-of-tolerance events or trends
AUTOMATION ENGINEERING (AE): Assist with lifecycle document changes within MSIT Change Management. Interact with AE to access system however I&C Engineer will own and define parameters
QUALITY: SME resource for I&C for Change Control assessment, Deviation investigations, CAPA plan development.

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