cGMP Validation Engineers

Company Name:
Exciting opportunity for Validation Engineers! Global Pharmaceutical company is expanding their site and looking to add Validation Engineers (Level DOE) to their teams here in Massachusetts! Engineers will be responsible for the following but not limited to:

Execute major engineering challenges pertaining to policies, plans, and objectives
Work with Manufacturing, Facility, and Quality Control design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities
Execute system improvements in conjunction with Manufacturing, Facilities, Quality Assurance, Validation and Regulatory
Develops solutions to a variety of complex problems which require the regular use of ingenuity and innovation
Provides Re-Qualification support for process equipment
Accountable for all phases of the Change Control process for owned changes
Owns and ensures timely closure of equipment related CAPAs
Provides and/or ensures generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
Provides peer review for all QA and Engineering documentation
Acts as project manager for small process equipment projects
Projects commissioning of equipment FAT / SAT
Develops engineering standard practices that will result in consistent, reproducible documents
Identifies equipment - specific best practices and performs gap analysis
Provides budgetary and schedule estimates for the requirements of projects
Communicates project requirements to vendors to obtain proposals for equipment and piping changes
Develops and executes engineering tests, FATs, SATs and commissioning test plans
Approves validation protocols
Troubleshoots and remediates exceptions during FAT/SAT/ IQ/OQ/PQ
May assist project manager with large projects

BS degree in Chemical or Mechanical Engineering, or related field; AND 5+ years GMP validation experience in Pharma industry.

Strong experience in manufacturing area
Experience in Washers, Sterilizers, Lyophilizers, Depyrogenation Ovens, Filling Lines, and clean process utilities
Experience with disposable technology and in a cleanroom environment is a plus
Familiarity with Kaye Validator 2000
Strong instrumentation and controls background
May be required to be on call

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