Validation Engineer jobs in Newark, NJ

Position Information: 

• Work Location: Piscataway, NJ / East Hanover, NJ
• Reports to: Validation Director 

Position Overview:

The position reports to the Validation Director/Manager and is ideally suited for a professional with background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Roles and Responsibilities:

•    Responsible for validation execution and documentation
•    Review and approve vendor validation protocols for technical accuracy and compliance
•    Execute validation protocols, write validation reports
•    Prepare validation protocols where applicable
•    Responsible for utility and equipment qualification execution
•    Represent QA role in utility, equipment, process and assay validation planning and execution
•    Participate in software validation as required
•    Interact with functional departments to ensure compliance in validation activities
•    Interface with contractors in validation activities

Qualifications:

•    BS in life science or related field
•    6 years experience in drug/biologics industry as validation engineer
•    4 years hands on experience in facility, utility, equipment, instrument validation
•    Experience in CSV helpful
•    Experience in cleaning validation and assay validation a plus
•    Familiar with GMP operational principles and documentation
•    Works independently, self-motivated, and results oriented