Validation & Engineering Group USA, Inc. (V&EG USA) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Engineer: Qualification of New Clean Rooms, Facilities and/or Utilities for RNA and/or Biotechnology Manufacturing Facilities
• Area: Norwood, MA

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct RNA and/or biotechnology manufacturing and packaging platforms.
• Have substantial experience with commissioning and qualification of utilities, facilities and/or clean rooms for aseptic RNA or fill/finish manufacturing facilities.
• Experience in Equipment Qualification – Clean process air, WFI, Clean Rooms.
• Experience in PQ – Clean rooms.
• Excellent communications skills (oral and written) in English.
• Excellent technical writing skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Available to work extended hours, possibility of weekends and holidays, if needed.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, ISO for Cleanrooms.

Responsibilities:

• Follow a Risk Based Approach and Testing Strategy.
• Responsible for the overall delivery and execution of the CQV scope of work including completing all CQV deliverables per scope of work.
• Creation/development, updates, and execution of CQV equipment lifecycle documentation: URS, FS, RS, Risk Assessments, Impact Assessments, VP, ETOPs, IOC, IOQ, PQ and associated Summary Reports related to facilities and utility systems.
• Creation/development, updates, and execution of validation documents relating to Manual Fill Operations (Media Fill PQs).
• Issuance and management of any discrepancies and deviations.
• Assist technical stakeholders in support of CQV activities and Project Implementation (Quality, Process Engineering, Project Managers, QC, MSAT, Engineering).
• Creation/development, updates, and execution of Environmental Monitoring PQ Plan and protocols for manufacturing rooms in scope.
• Communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
• Ability to work independently while maintaining communication with all team members.
• Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
• Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.