Job Summary
We are seeking a highly skilled and experienced Senior Engineer, responsible for supporting drug product filling operations and working in a matrix team environment to achieve project objectives.
Key Responsibilities:
* Technical SME for drug product (DP) supporting filling operations
* Develop process comparisons, risk assessments, and manage DP technical and manufacturing risks
* Author technical reports to support DP process and product characterization
* Manage change control, deviations, and CAPAs through the quality management system
* Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations
* Initiate and lead process improvement projects, involving cross-functional teams
* Support the technical delivery of new product introductions and tech transfer projects
Requirements
Applicants must have a strong understanding and hands-on experience in MSAT or process development or technology transfer, with a background in large-scale processing of biologic drug products. Additionally, they will possess excellent organizational, interpersonal communication, and problem-solving skills, as well as the ability to build strong partnerships and work effectively with diverse team members in a dynamic environment.
Qualifications:
* Strong understanding and hands-on experience in MSAT or process development or technology transfer
* Background in large-scale processing of biologic drug products
* Solid understanding of regulatory requirements and guidelines
* Proficient in technical writing
* Excellent organizational, interpersonal communication, and problem-solving skills
* Able to work on the manufacturing floor for extended periods during the execution of technical protocols
About This Role
This is an exciting opportunity for an individual who is passionate about driving innovation and improving processes within our organization. The ideal candidate will be a collaborative and results-driven professional who thrives in a fast-paced environment.
Why Choose Us?
Our company is a global leader in the biotechnology industry, dedicated to developing innovative solutions that improve human health. We offer a dynamic and supportive work environment, where employees can grow professionally and personally.
Equal Opportunity Employer