What are the responsibilities and job description for the Validation Specialist III position at The Fountain Group?
Currently I have an opening for a Validation Specialist III located in Swiftwater, PA. Details for the position are as follows:
Job Description:
Job Description:
- This position of Validation Specialist III, in the Manufacturing Science Technology and Analytics (MSAT) function of M&S-V, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized to produce vaccines and biologics.
- Key contributor for strategy development and execution of development and process validation related to adjuvant manufacture.
- Provides input to industrialization strategies and rationale for critical process parameters
- 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
- Develop and execution of training programs for appropriate audiences
- Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
- Ownership of equipment unit operations and technology capabilities and 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,
- Bachelors degree required with 2 years of experience in the pharmaceutical or biotech industry supporting process validation. Position will support CQV across plant utilities, clean utilities, HVAC, Filling lines, CTUs, component prep equipment, and formulation.
- Pay: $65-83 hourly, depending on experience level (Hiring 2 people!)
- Onsite, M-F, 8am-5pm
- 8-month contract, potential for extension/conversion
Salary : $65 - $83
