This position is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the industrial sites. The mission is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC).
Job Responsibilities:
Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs.
Support execution of development and validation related studies.
Document and interpret study results with recommendations.
Provide technical leadership as a subject matter expert in multiple areas of responsibility.
Develop and execute training programs for appropriate audiences.
Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
Provide leadership, including project team leadership, within area of expertise.
Assist with assessing existing processes and workflows.
Translate processes to commercial operations.
Ownership of equipment unit operations and technology capabilities.
Communicates findings and proposals to upper management.
Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.
Education & experience:
BS or MS in basic sciences, math, engineering or pharmacy with 2+ years' experience or PhD with experience in biological processes or analytics in a cGMP environment.
Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Validation and Quality background is needed, they need to have both.
Sterilization validation would be a plus.
Equipment validation is important.
Might be final approver for documents.
Reviewing and approving validation / qualification type documents a major plus.
Detail oriented. Strong working knowledge of Quality System Regulations.
Experience leading CAPA (Corrective and Preventive Action) activities.
Excellent written and oral communication skills.
Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Experience in equipment start-up, qualification and validation is preferred.
Prior experience preparing and executing process performance qualification documents (PPQ) preferred.
The hourly range for roles of this nature are $60.00 to $90.00/hr. Rates are heavily dependent on skills, experience, location, and industry.