Job Description
Insight Global is seeking a team of Validation / Commissioning Engineers to support validation and startup activities within its biologics manufacturing facility in Raleigh-Durham. This role is heavily focused on validation execution, protocol development, and hands-on commissioning activities within a fast-paced GMP environment. The team is looking for engineers who are comfortable working both at a desk and in the field, with a strong emphasis on equipment troubleshooting, startup support, and practical problem-solving.
Responsibilities:
· Author and develop validation protocols using standardized templates (IQ/OQ/PQ)
· Drive protocols through cross-functional review and approval with Engineering and Quality
· Execute protocols in the field, including:
o System walkdowns
o Startup testing and shake-down activities
o Troubleshooting equipment issues during execution
· Complete post-execution documentation, deviations, and validation reports
· Support commissioning activities including:
o First-time equipment startup
o Equipment stand-up and readiness
· Partner with Engineering, Quality, Automation, and Operations to ensure systems meet GMP and design requirements
· Utilize CMMS/work orders to support equipment startup and commissioning activities
Maintain strong documentation practices aligned with GMP standards
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
Must haves:
- 2-5 years of experience with hands on commissioning & execution, not just documentation
- Experience a blend of the below equipment
§ Large stainless-steel tanks (100L–12,000L)
§ UF skids and chromatography systems (more complex systems)
§ Pumps, heat exchangers, and related downstream equipment
§ Will take upstream or downstream experience
§ Need at least 1 full year with large scale operations biotech experience – pumps, bioreactors, big stainless-steel equipment
o Includes:
§ Commissioning / first-time startup activities
§ Shakedown testing & startup testing, troubleshooting during execution
- Strong experience with protocol execution – IQ/OQ/ PQ execution
o Drafting validation protocols
o Review & approval with quality & engineering
o Executing those protocols in the field
o Completing post approval documentation
Nice to Have Skills & Experience
Pluses:
- Greenfield experience
Expereince with Kneat
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.