Validation Engineer II

Location: Waltham, MA

Job Description

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Development and review of technical documentation including:
    • Standard Operating Procedures
    • User Requirements and Design Specifications
    • Commissioning and Qualification Protocols
  • Execution of validation test procedures
  • CAPA and Change Management
  • Thermal mapping of Autoclaves and SIP processes
  • Technical report writing
  • Data Analysis
  • P&ID walkdowns
  • Performs/executes/validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.
  • Prepare and review SOPs and other documents for compliance and provide guidance and counsel to staff as needed.
  • Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.
  • Develop and complete deliverables related to QA activities as needed to ensure objectives are met.
Requirements
  • BS in Engineering, Science or equivalent technical degree.
  • At least 3 years’ experience of validation and/or Quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong communication, interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • In-depth understanding of various FDA regulations/guidance including 21CFR Part 11
  • Ability to travel to client sites throughout the New England region.


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