Validation Engineer - Shipping
Marin Metro Area, CA
- Responsible for biological and/or small-molecule process validation activities in a cGMP environment.
- Coordinate and manage process validation projects related to the implementation of material packaging and shipping processes and changes to existing processes.
- Be a key contributor assisting with change control and regulatory responses in addition to the presentation of process validation activities during regulatory agency/partner audits and inspections.
- Other responsibilities include: protocol generation, project management, protocol execution, final summary report generation and other duties as assigned.
- Provide project management oversight for process validation activities related to biologic/small-molecule material packaging and shipping operations.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured, validation techniques/approaches and systems utilized at the company s Represent Validation in multi-departmental meetings & project teams owned by QAV Shipping Process.
- Generation of process validation master plans, core validation master plans and additional supporting documentation.
- Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal laboratories.
- Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
- 5+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- Training in project management is preferred.
- Experience and proficiency with other applications (such as Trackwise, JMP, MS Access a plus).
- Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.