Principal Process Controls & Validation Engineer

Role Summary

Principal/Staff Process Controls & Validation Engineer for Labeled Drug Product fill/finish manufacturing processes. Provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities. This role involves working Monday-Friday, 8am-4:30pm.

Responsibilities

• Provides technical support to 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 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 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.

Qualifications

• Willing and able to work Monday-Friday, 8am-4:30pm.
• BS/BA in Engineering; Biomedical Engineering or Chemical Engineering preferred.
• Principal: 8+ years in Drug Product/Labeled Drug Product.
• Staff: 10+ years in Drug Product/Labeled Drug Product.
• Or equivalent combination of education and experience in Drug Product/Labeled Drug Product.
• Experience in aseptic processing, drug product development, labeled drug product processing, or biopharmaceutical/combination product validation is required.

Skills

• Advanced problem solving, including addressing ambiguous issues and situations.
• Project scoping with process steps, schedules, risk communication.
• Ability to adapt to changing priorities.
• Ability to influence a non-technical audience using technical expertise.

Education

• BS/BA in Engineering; Biomedical Engineering or Chemical Engineering preferred.