Execute specific technical tasks within a project, ensuring high-quality deliverables.
Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead’s guidance.
Report technical issues to the Site Lead and support resolution efforts.
Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards.
Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
Identify and close individual knowledge gaps with support from other team members or leads as needed.
Execute system and process validation protocols by using GxP best practices.
Support necessary billables as forecasted by site dashboards on billable targets per month.
Report workload or skill gaps within assigned tasks.
Communicate updates internally in a timely manner and relay in-field project decisions to highlight long-range, down-stream project and team impacts.
Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
Perform due diligence on system and subject domains to generate high-quality project deliverables.
Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks.

Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx / OpEx project management and/or comparable military experience)
1-5 years in consulting and/or engineering services
Willingness to travel as required for client project assignments.
Full-time on-site client presence
Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position.
This position may require significant travel to support project and business needs.
We cannot employ anyone with an invalid driver's license.

Senior Validation Engineer – cGMP

Key skills