Commissioning Partners ยท 12 hours ago
Validation Engineer
Hopewell, NJ
Full-time
Onsite
Senior Level
7+ years expCommissioning Partners is focused on biologics manufacturing, and they are seeking a Validation Engineer to support their New Product Introduction program. The role involves leading Cleaning Validation activities and ensuring compliance with GMP and regulatory expectations throughout the project lifecycle.
Pharmaceuticals
Responsibilities
Lead all CIP and SIP validation activities for the NPI program
Develop, review, and execute cleaning validation protocols and reports
Design and optimize CIP and SIP cycles for:
Process piping
Transfer panels
Bioreactors
Perform hands-on execution including:
Rinse and swab sampling
Visual inspections
Riboflavin coverage studies
Develop and justify load patterns for:
Autoclaves
Parts washers
Glass washers
Support tech transfer activities and integration into manufacturing operations
Collaborate closely with Engineering, Automation, Manufacturing, and Quality teams
Ensure all activities meet GMP and regulatory expectations
Qualification
Required
7 10 years of validation experience within pharmaceutical or biologics manufacturing
Minimum 5 years of direct Cleaning Validation experience
Proven hands-on experience with: Rinse and swab sampling techniques, Visual inspection methods, CIP and SIP cycle development, Autoclave and washer load pattern development, Riboflavin study execution
Strong experience working with DeltaV automation for CIP and SIP systems
Preferred
Experience using Ellab ValSuite Pro
Experience with ValGenesis for electronic protocol authoring, execution, and review
Company
Commissioning Partners
In the ever changing world of staffing - we understand the need of our client with utmost priority and respect and offer them a customised solution for their needs.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase