Principal Process Controls & Validation Engineer

BioSpace; Town of East Greenbush (NY); On-site; USD 90,000 - 174,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Principal Process Controls & Validation Engineer, der die Labeled Drug Product Fill/Finish Manufacturing Prozesse unterstützt. In dieser spannenden Rolle werden Sie technische Unterstützung bieten, Risiken bewerten und Daten analysieren, um die Robustheit der Prozesse zu gewährleisten. Sie arbeiten eng mit verschiedenen Teams zusammen, um sicherzustellen, dass die SOPs und Validierungspläne den Branchen- und Regulierungsstandards entsprechen. Wenn Sie über umfangreiche Erfahrung in der aseptischen Verarbeitung und der biopharmazeutischen Validierung verfügen, ist dies eine hervorragende Gelegenheit, Ihre Fähigkeiten in einem dynamischen Umfeld einzusetzen.

Benefits

Umfassende Gesundheitsprogramme

Bonussystem

Bezahlter Urlaub

Qualifications

• 8+ Jahre Erfahrung in aseptischer Verarbeitung oder biopharmazeutischer Validierung.
• Erfahrung mit Füll- und Abschlussprozessen ist erforderlich.

Responsibilities

• Technische Unterstützung für Technologie- und Designübertragungen.
• Analyse von Daten zur Sicherstellung der Prozessrobustheit.

Skills

Aseptische Verarbeitung

Datenanalyse

Prozessvalidierung

Technologieübertragung

Education

Bachelor in Ingenieurwesen

Job description

Principal Process Controls & Validation Engineer

Join to apply for the Principal Process Controls & Validation Engineer role at BioSpace.

Regeneron is seeking a Principal/Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This full-time role follows a Monday-Friday, 8am-4:30pm schedule. The Process Sciences department provides technical support across scientific, engineering, and manufacturing disciplines, from laboratory to production. The role involves supporting manufacturing, quality, and CMC Regulatory activities from technology transfer through post-commercial lifecycle management.

Key Responsibilities:

• Provide technical support for technology transfer, design transfer, process control strategy development, process validation lifecycle, and post-commercial activities.
• Evaluate product and process risks during various transfer and validation phases.
• Analyze data from development to manufacturing to ensure process robustness.
• Collaborate with Manufacturing, Quality Control, Quality Assurance, and CMC regulatory teams.
• Author protocols, reports, and technical documents with conclusions based on process and product knowledge.
• Ensure SOPs, policies, and validation plans meet industry and regulatory standards such as ICH guidelines.
• Support audits, inspections, and regulatory submissions as needed.
• Apply engineering principles to develop and execute process controls and validation strategies.
• Analyze manufacturing data using statistical and engineering techniques.
• Develop KPIs and monitor business health.
• Improve cross-functional processes and work effectively in a team environment.
• Support laboratory and manufacturing studies.

Qualifications:

• Bachelor's degree in Engineering (Biomedical or Chemical preferred).
• 8+ years for Principal level; 10+ years for Staff level experience in aseptic processing, drug development, or biopharmaceutical validation.
• Experience with fill-finish processes is required.

Additional Information:

Willingness to work Monday-Friday, 8am-4:30pm. Candidates should have experience in aseptic processing, drug development, or biopharmaceutical validation.

Salary range: $90,800 - $173,400 annually.

Other details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Engineering and IT

Regeneron values diversity and is an equal opportunity employer. We offer comprehensive benefits, including health programs, bonuses, and paid time off. Background checks will be conducted in accordance with local laws.