Cleaning Validation Engineer

Day to day :
A large pharmaceutical client is seeking a team of Cleaning Equipment Validation Engineers to support their site build out in Raleigh0Durahm. The ideal candidate will have hands on validation experience, documentation experience and experience working within regulated pharmaceutical environment. The first 3-4 months will be heavily focused on documentation and protocols. Once engineering runs begin in the fall, the role will move into the field supporting cleaning validation activities on the floor. Samples will be taken, protocols filled, and swaps taking place. Mid next year the site will move into 24/7 operations.

Responsibilities:
- Conduct PQs for parts washers and other cleaning equipment
- Define cleaning parameters & take samples
- Assist with CIP procedures and systems
- Communicate with vendors and teams onsite
- Develop and execute cleaning validation protocols and reports for new equipment and facilities.
- Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
- Conduct cleaning validation studies, including sampling, testing, and data analysis.
- Investigate and resolve deviations and discrepancies related to cleaning validation.
- Maintain accurate and detailed documentation of all cleaning validation activities.

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/.

Must Haves:
- 4+ years of experience with cleaning validation
- Bachelors Degree in Engineering or related field
- Experience with cGMP documentation and validation life cycle
- Experience writing cleaning validation reports, risk assessments, protocols and investigating and resolving deviations
- Experience with Kneat – high preference for this
- Experience with greenfield, brownfield or new facility build outs desirable

Pluses:
- Cleaning validation experience with both small parts & large scale equipment like bioreactors

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.