Validation Engineer Location: Amesbury, MAPosition Overview The Validation Engineer will be joining a growing manufacturing and development organization in the Amesbury, MA area! This role will report to the Associate Director of Maintenance and Engineering. The Validation Engineer will be responsible for overseeing the sites Validation program and ensuring equipment and systems remain in a qualified, operational state of compliance associated with cGMP manufacturing. Responsibilities
- Lead quality system improvements for the validation program.
- Write and execute Validation protocols including Installation, Operation, Performance and Cleaning Qualification documents.
- Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformance's encountered during qualification activities.
- Assist in investigating deviations related to facilities, utilities, and equipment.
- Write and revise Standard Operating Procedures (SOPs).
- Identify gaps in existing program and devise improvements.
- Take ownership of projects to achieve schedule, financial and technical goals.
- 5+ years of related field/experience or AS in Engineering (chemical or mechanical)
- 10+ years of related experience