Senior Specialist Process Microbiologist

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

At our Company campus in Elkton, Virginia, we currently have openings for Senior Specialist Process Microbiologist position available on our Technical Operations team.  The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University. A successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of biologic, vaccine, and sterile product manufacturing facilities.

Responsibilities include:

• Achieving Safety, Quality, and Environmental compliance excellence in all assignments

• Managing multiple technical and capital projects and assembling and leading multidisciplinary teams across many functional areas

• Learning new processes and procedures

• Leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation

• Writing, reviewing, improving documentation for technical and regulatory compliance excellence

• Teaching, coaching, mentoring, and learning from team members

• Provide ongoing coaching and support to the IPT team members, to share their aseptic technical knowledge and promote best practices.

• Education and communication of personnel in Aseptic techniques, GMP requirements and regulations

• Microbiology Representative on Technical Agenda Teams and investigations

• Collaborates in the development and execution of the Facility-based Environmental Monitoring programs to include QRA execution.

• Process microbiology representative for Facility and Equipment Qualification Requirements

• Provides aseptic guidance on facility and process-related controls and changes.

• Has a good working knowledge of Analytical Microbiology Requirements and Systems

• Handling of non-conforming EM results and trend analysis

• Troubleshooting of suspected Microbiological Contamination incidents

• Participation in internal and external audits

• Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc.

• Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

• Execution of Sterility and Environmental Quality Risk Assessments

Education Minimum Requirement:

• B.S. or B.A. degree in Biology,Microbiology or equivalent

• Minimum of five (5) years in manufacturing environment that includes quality assurance, quality operations, or engineering.

Required Experience and Skills:

• Strong problem solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.

• Project management skills and experience

• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.

• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.

• Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.

• A strong desire to succeed and to help others to do the same.

• Working knowledge of regulatory expectations of Aseptic processing.

• Ability to interact directly with regulatory agencies

• Proficiency in the use of Microsoft Office Suite.

Preferred Experience and Skills:

• Working in a cGMP environment

• Biologics or vaccine processing

• Sterile processing

• Leadership