Quality Change control

Qualifications:
Education Minimum Requirement:
• Bachelor's Degree in Engineering or Science
Required Experience and Skills:
• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry
• 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:
• Strong understanding of Change Control and Project management
• 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
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
• Experience with introduction of process changes to a licensed process

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. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• 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.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.