Lab Technical Operations Coordinator - LTOC24-13786

Position:  Lab Technical Operations Coordinator
Location: Elkton, VA 22827  
Duration:  12 Months

Responsibilities:

• The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture.
• In this role, the contracted person will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department.
• Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.

Additional responsibilities include:

• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science.

Required Experience and Skills:

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
• Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.

Preferred Experience and Skills:

• Demonstrated ability to work both independently and as a part of a team.
• Strong technical problem-solving abilities.
• Demonstrated effective written and verbal communication skills.
• Strong collaboration skills.
• Equipment Troubleshooting
• Experience with introduction of process changes to a licensed process.