We are seeking a Process Validation Engineer to join our dynamic team at our Chelsea Parkway site. This role is pivotal in ensuring successful product development, technical transfer, and validation activities across manufacturing operations.
Requirements
- Develop and own the master process validation plan; act as SME for process development.
- Collaborate with Product Development teams to ensure successful technical transfer to manufacturing.
- Coordinate and execute validation activities including protocols, MBRs, reports, change controls, deviations, and CAPAs.
- Author Product Quality Review Reports and Continued Process Validation Reports.
- Maintain compliance with GMP, federal and state regulations, and internal quality standards.
- Lead and support process improvement initiatives using lean manufacturing tools.
- Provide engineering support for equipment and manufacturing processes.
- Manage technical documentation including SOPs, standards, and drawings.
- Develop and update SOPs and templates for the Engineering team.
- Maintain up-to-date knowledge of pharmaceutical regulations and interpretations.
- Represent validation on site project teams and cross-functional initiatives.
- Develop and execute cleaning validation plans and process development batches.
- Lead risk assessments for process and cleaning validation.