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Senior Validation Engineer

2 months ago

Bradley, Illinois, United States MMR Consulting Full time
About the Role

MRR Consulting is seeking a highly skilled Senior Validation Engineer to join our team. As a Senior Validation Engineer, you will play a key role in the commissioning, qualification, and validation of various systems within the pharmaceutical and biotechnology industries.

Key Responsibilities
  • Provide technical guidance and expertise in the commissioning, qualification, and validation of pharmaceutical and biotechnology process equipment, utilities, and facilities.
  • Lead the development and execution of qualification deliverables, including DQ, FAT, SAT, IQ, OQ, and PQ, during the project lifecycle.
  • Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
  • Engage with other departments, including process, mechanical, architectural, facilities, and electrical, to ensure timely completion and adherence to quality and engineering specifications.
  • Review Factory Acceptance Testing (FAT) protocols and leverage for commissioning, as required.
  • Review of P&IDs and establishing system boundaries.
  • Generation of System Test Matrix.
  • Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.
  • Visit construction and installation sites, wearing necessary safety PPE.
  • Lead/Mentor a team of validation engineers/specialists.
Requirements
  • 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry, knowledge of requirements for cGMP operations.
  • Experience with commissioning & qualification of equipment & facilities is required.
  • Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is required.
  • Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
  • Experience with commissioning and qualification of biotech process equipment, such as autoclaves, washers, and clean utilities, is required.
  • Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs.
  • Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
  • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
  • Possess mentorship skills, to coach and develop junior and intermediate employees.
  • Engineering degree, preferably in Mechanical, Electrical, or Chemical.
  • Travel may be required on occasion.
  • Ability to handle multiple projects and work in a fast-paced environment.
  • Strong multi-tasking skills.
About MMR Consulting

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries in North America and globally. Our services include engineering, project management, validation, and other consulting services. We have expertise in process, automation, facilities engineering, and pharmaceutical expertise in oral solid dosage, semi-solids, liquid-dosage, API manufacturing, and biotechnology.