Cleaning Validation Engineer Job at Insight Global, Holly Springs, NC

d2s3Qm5MTEtOQmoxbThCYjVkQy9uYkQ5eEE9PQ==
  • Insight Global
  • Holly Springs, NC

Job Description

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.

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

Job Tags

Similar Jobs

Randstad Enterprise

Machine Millwright Job at Randstad Enterprise

 ...mechanical aptitude and attention to detail Must provide own tools Special Credentials / Skills Demonstrated ability to install, repair, troubleshoot, and maintain machinery and equipment Skilled in dismantling and moving stationary industrial equipment (pumps... 

Nuestro Mundo Public Charter School

Dual Langauge Teachers Job at Nuestro Mundo Public Charter School

 ...sustainability principles aligned with the U.N.'s Sustainable Development Goals (SDGs) and offers Dual Language Immersion in English and Spanish. Students at Nuestro Mundo not only receive core academic instruction but also engage in learning about climate change, global... 

@Orchard LLC

Deckhand Job at @Orchard LLC

Deckhand NOAA Research Vessel Support (Levels I & II) Remote/Offshore within Massachusetts or Rhode Island accessible to Falmouth/Woods Hole, MA, and Narragansett, RI (with assignments on NOAA and partner vessels throughout the Northeast U.S.) @Orchard LLC has...

AIM World Services

Heavy Equipment Diesel Mechanic Job at AIM World Services

 ...apply here. This position is open to internal and external applicants. Summary The Heavy Duty and Diesel Mechanic diagnoses, adjusts, repairs and overhauls buses and trucks, and maintains and repairs various of diesel engines. The incumbent will also perform... 

Engage Engineer Search

Structural Engineer Job at Engage Engineer Search

 ...Forensic Structural Engineer &##128205; Hiring in Tampa, FL | Remote Role with 50% Local Travel &##128176;$120K$140K Base + Year-End Bonus &##127873;Full Benefits | 401(k) About the Company A well-established structural forensic engineering firm is seeking...