We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY
Manage and prioritize all phases of assigned validation projects from concept through process validation and ongoing support of cGMP operations. They ensure cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. Able to contribute at a high level in at least 2 of the following disciplines; Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique.
ESSENTIAL FUNCTIONS
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.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Required
• 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
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
