Validation Engineer II

Job Locations US-MA-Bedford
Posted Date 1 month ago(8/15/2022 11:08 AM)
Job ID
2022-1613
# of Openings
1
Category
Engineering

Overview

The Validation Engineer II will support the validation activities associated with process, cleaning, equipment, utilities, facility and computerized systems.  Validation activities include Commissioning, Qualification (IQ, OQ and PQ), Process Validation, Cleaning Validation, and generation of User Requirements Specifications (URS) and other controlled documents.  The validation engineer will also ensure the maintenance of the validated state of GMP manufacturing systems used to support clinical development and commercial manufacture of multiple therapeutic drug substances. 

 

The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks. 

Responsibilities

  • Provide technical input to strategy/philosophy for validation activities
  • Support the execution of routine and non-routine validation activities involving the qualification of new and existing facilities, utilities, equipment, cleaning and process validation.
  • Generate, execute, and lead equipment and facility validations, reviewing and analyzing data, and adhering to GMP regulations.
  • Support cross-functional teams to establish project validation master plans, cleaning validation master plans, etc. for complex product development projects.
  • Represent process validation during tech transfer activities as required.
  • Support validation activities related to drug delivery product/device development, and in-house commercial manufacturing.
  • Support Change Control activities, deviation resolution (CAPA), and effectiveness checks for validated systems.
  • Support decommissioning activities for retired or end of life systems.
  • Participate in project teams executing various validation projects and communicate project plans, status updates and progress against milestones to project team members.
  • Maintain up to date knowledge of evolving regulatory requirements regarding validation and GMP, and act as an information resource for the team and business stakeholders.
  • Support internal and external audits and regulatory inspections.
  • Perform other validation engineering duties as assigned.

Qualifications

  • Bachelor’s degree in Chemistry, Biology, Pharmaceutics, Biomedical, Chemical Engineering or related discipline
  • 2+ years of validation experience in pharmaceutical or medical device development.
  • Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 211 regulations.
  • Understanding of quality systems such as change control and discrepancy investigation.
  • Demonstrated written and verbal communication skills.
  • Demonstrated data analysis skills.
  • Proficient with Microsoft Office, particularly Word and Excel.
  • High degree of initiative and self-motivation.
  • Experience creating technical, written content.
  • Ability to manage and meaningfully advance diverse tasks and projects.

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