Description
TSMS - Senior Process Validation Engineer
The Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide advanced technical leadership to ensure robust and reliable production processes are established and maintained across multiple programs.
This position will lead the delivery of technical guidance and assistance throughout the process validation of production processes. The primary objective is to independently execute Process Performance Qualifications and Continued Process Validation activities while mentoring junior staff.
Essential Job Functions:
- Lead TSMS Process Validation activities by providing advanced technical guidance to operations and technical transfer project teams on Process Performance Qualification with minimal supervision
- Independently create complex process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents for multiple product lines
- Serve as technical lead in project teams and manage customer communications. Recognized as Subject Matter Expert for multiple manufacturing processes
- Author and review complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms across multiple programs
- Monitor and analyze Process Data across multiple manufacturing areas, identify trends and implement corrective actions independently
- Lead technical troubleshooting and investigations of complex process issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions
- Lead cross-functional teams in assessing and implementing new technology for GMP manufacturing with strategic impact
- Provide advanced technical guidance to team members in technical matters of process validation and mentor Entry Level engineers
- Conduct comprehensive impact assessments of changes to the product, process, equipment, procedures and/or materials across multiple programs
- Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions
- Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions
- Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact
- Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members
- Other responsibilities as required
Special Job Requirements:
- Bachelor's degree in Science or Engineering required
- Master's degree in Science or Engineering preferred
- 3-5 years of GMP experience required
- 2+ years of experience in process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes
- Strong understanding of CMC regulatory requirements and process validation methodologies
- Advanced analytical and problem-solving skills with demonstrated leadership capabilities
- Excellent communication skills and proven ability to lead cross-functional teams and manage client relationships
- Advanced proficiency in Microsoft Office applications, statistical analysis software, and data analysis tools
- Demonstrated ability to work independently in a fast-paced, regulated manufacturing environment
- Experience with regulatory submissions (preferred) and client-facing technical presentations
