Validation Consultant - Remote - Boston Area
The full-time Validation Consultant will provide validation services for our clients in the biotech and pharmaceutical industries with a focus on plant automation, specifically Emerson’s DeltaV DCS. The Validation consultant will work on project teams to assist with the validation and testing of GMP compliant systems and is expected to perform various roles in the validation process, including creating and executing IQ or OQ test scripts, developing validation plans and performing risk assessments. In addition, this role requires close interaction with clients and the ability to work and communicate with both team members and external stakeholders.
- Strong background in validating systems in a FDA regulated environment. Prefer experience with distributed control systems such as Emerson’s Delta V or Honeywell Experion but will also consider validation work performed on computer software in a GMP environment
- Bachelors degree in a relevant area such as Operations, Computer Science, Engineering or Business Administration
- Understanding of the validation requirements and protocols including GAMP, 21 CFR part 11 and GMP
- Ability to travel to client sites when necessary
- Openness to career development and feedback to promote future job advancement
Travel: Up to 75% based on client location