MSAT Engineer I-II Process Validation

The Process Validation Engineer I/II is responsible for supporting GMP cell culture manufacturing operations, developing new technologies/equipment, and implementing process improvements. They assist in the development and maintenance of the Drug Substance Process Validation program, author and maintain the Process Validation Master Plan, and participate as a representative on client project teams. They provide technical assistance to various departments, support deviations and investigations, and develop risk-based strategies for process validation. The Process Validation Engineer I/II also participates in regulatory inspections and inspection readiness activities.

• Assist in development and maintenance of all aspects of Drug Substance Process Validation (PV) program
• Author and maintain overall Process Validation Master Plan
• Participate as PV representative on client project teams
• Prepare and provide data associated with manufacturing processes for internal and external clients
• Author and review characterization and validation protocols and reports
• Develop and maintain strong relationships with Process Development (PD), Manufacturing Science and Technology (MSAT), Manufacturing, Quality Control (QC), and Quality Assurance (QA)
• Provide hands-on support in the execution and maintenance of the validation program
• Provide technical assistance to Manufacturing and other departments associated with GMP operations
• Provide validation support to deviations, investigations, CAPAs, Change Controls, and process issues
• Develop and apply risk-based strategies for process validation throughout product lifecycle
• Assist in authoring and reviewing relevant technical sections of regulatory dossier or other communications to health authority
• Support Global PV initiatives and process improvement initiatives
• Interact extensively in a team environment with multi-disciplinary teams
• Participate in regulatory inspections and inspection readiness activities as PV representative

• Technical competency in process validation requirements
• Knowledge and understanding of current GMP regulations and industry standards regarding process validation, particularly in Biologics Drug Substance manufacturing, in compliance with FDA/EMA regulations and ICH guidelines
• Knowledge and experience in process validation studies at the bench and in a plant setting
• Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable
• Demonstrated ability to interface/communicate extensively with internal and external clients
• Proven experience successfully managing multiple projects simultaneously
• Motivated, dependable, detail-oriented, organized, and willing to perform both routine tasks and develop new skills
• Strong presentation skills
• BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred
• 0-2 or more years' relevant experience for Level I position

• Subsidized insurance for medical, vision, dental, life, and disability for the employee and dependents
• Eligibility to participate in the AGC Biologics 401(k) plan with a generous matching contribution and immediate vesting
• Vacation, sick time, and parental leave
• Discretionary annual bonus based on company and individual performance
• Highly competitive compensation package
• Friendly and collaborative culture
• Equal opportunity employer