Principal Process Controls & Validation Engineer

Principal Process Controls & Validation Engineer

Requirements

• BS/BA in Engineering; Biomedical engineering, Chemical Engineering preferred
• Principal Process Controls & Validation Engineer: 8+ years of experience
• Staff Process Controls & Validation Engineer: 10+ years of experience
• Experience with fill finish is required
• Experience in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation is preferred

Responsibilities

• Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
• Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
• Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history
• Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle
• Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed
• Applies engineering principles to the development and execution of process controls and validation strategies
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control
• Develops and monitors health of the business using key performance indicators
• Develops and improves cross-functional business and manufacturing processes
• Works effectively and efficiently in a team-oriented environment
• Provides support to laboratory studies and/or studies performed at manufacturing scale

Preferred Qualifications

• Can perform advanced problem solving including addressing ambiguous issues and situations
• Can accurately scope projects – break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk (process management, measuring & managing work)
• Can deal with changing priorities and are able to adapt to change
• Can use technical expertise to influence a non-technical audience on a path forward