Validation Engineer 2
Emergent BioSolutions
- Baltimore, MD
- Permanent
- Full-time
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Possesses strong knowledge of validation and related practices, including governmental regulations
- Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies
- Reviews and approve validation related system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)
- Perform hands on field work for equipment, aseptic processing, steam sterilization, cleaning validation, and process validation and their associated control systems
- Uses proven monitoring and problem-solving techniques such as SPC and DMAIC
- Provide customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Validation department
- Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents, and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk
- Act as a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self as well as colleagues
- Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.
- Experienced professional with full understanding of work; resolves a wide range of issues in creative ways.
- Work on problems of increasingly diverse scope; analysis of situation/data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for resolving issues and obtaining solutions.
- Receives little instruction from supervisors, general instructions on new assignments.
- Drive the complete execution of assigned projects in manner that drives high engagement from project team members.
- A minimum of 5 years of experience in a biopharmaceutical or related environment in the area of system qualification or validation
- BS in Engineering, Science, Project/Program Management
- Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and compliance for these technologies
- Ability to think and act both strategically and tactically
- Highly effective verbal and written communicator at all levels of the organization
- Demonstrated ability to effectively prioritize and coordinate activities
- Proficiency in Microsoft Office applications and validation specific software programs
- Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
- Possesses knowledge of current validation best practices, including governmental regulations and GxPs.
- Subject Matter Expertise in 1 of the following Validation disciplines: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique