Validation Engineer II

Location: Bedford, MA

Position Scope:

Performs start-up, commissioning, qualification, validation and revalidation for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device and drug product manufacturing processes. 

Strategic Focus Areas:

Develops into a subject matter expert in cleaning and sterilization validation.

Specific Tactical Responsibilities:

  • Authors, executes, and summarizes qualification and validation protocols.
  • Conducts Risk / Impact Assessments and establishes system boundaries.
  • Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs. 
  • Provides technical input in determining strategy for validation activities.
  • Represents validation during site GMP activities and participates on cross-functional teams. 
  • Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
  • Initiates, or provides validation input on quality systems such as CAPAs and change controls.
  • Responsible for other duties and projects as assigned

Job Complexity:

The job requires the ability to act on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.  The position exercises broad judgment within generally defined procedures and practices to determine appropriate action and exercises

Supervisory Responsibilities:

None

Required Qualifications:

  • BS degree in engineering or scientific discipline. 
  • 3-5 years of validation experience in bio/pharmaceutical, medical device or FDA regulated environments.

Desired Experience, Knowledge, and Skills:

  • Knowledge of the fundamentals of Steam Sterilization and Cleaning Validation.
  • Knowledge of quality risk management and statistical tools within the context of validation.

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.