Principal Process Controls & Validation Engineer

Role Summary

Principal/Staff Process Controls & Validation Engineer supporting Labeled Drug Product fill/finish manufacturing processes. Provides technical support to manufacturing, quality, and CMC Regulatory for processes from technology transfer to post-commercial lifecycle management. Monday–Friday, 8:00 am–4:30 pm schedule.

Responsibilities

• Provides technical support to technology transfer, design transfer, process control strategy development, process validation lifecycle, and post-commercialization activities.
• Evaluates product and process risks during transfer and lifecycle activities.
• Analyzes information and data from development through late-stage characterization and at-scale manufacturing history.
• Liaises with Manufacturing, Quality Control, Quality Assurance, and CMC regulatory to manage the process lifecycle.
• Authors protocols, reports, and technical documents with conclusions based on process and product knowledge.
• Ensures alignment of SOPs, validation plans, and internal documentation with industry and regulatory expectations (e.g., ICH).
• Supports audits/inspections and drafts CMC sections of regulatory submissions as needed.
• Applies engineering principles to develop and execute process controls and validation strategies.
• Analyzes data using statistics and engineering principles to gain insights into process performance and control.
• Develops and monitors key performance indicators and cross-functional processes.
• Works effectively in a team-oriented environment.
• Supports laboratory studies and studies at manufacturing scale.

Qualifications

• BS/BA in Engineering; Biomedical or Chemical Engineering preferred.
• Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product.
• Staff Process Controls & Validation Engineer: 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 and handling ambiguous issues.
• Skill in scoping projects, scheduling, and risk communication.
• Adaptability to changing priorities.
• Ability to influence non-technical audiences using technical expertise.