Validation Engineer - Katalyst Healthcares & Life Sciences
Norwich, NY 13815
About the Job
Responsibilities:
- Support/Author and/or Approve Mfg. Process Validation Protocols and Reports.
- Support/Author Equipment PQ and/or approve Equipment PQ Protocols and Reports.
- Provide backup coverage on Cleaning Validation documentation and provide technical support on the system.
- Provide backup coverage on Facility and Utility Qualification- write, review, approve commissioning/qualification documentation.
- Provide backup coverage on Equipment and Instrumentation qualification- write, review, commissioning/qualification documentation.
- Support the CPV program for Mfg. and Cleaning Validation programs.
- Author Risk Assessments and technical justification documents to support Validation Readiness and Production support.
- Represent/Support the Department in audits or regulatory inspections fielding questions related to the above systems and programs.
- Facilitate/Support validation training on the above systems.
- Co-Own and provide input to the Validation Master Plans for the Site, Process Validation, Cleaning Validation, Equipment, Facility, and Utility Qualifications.
- Provide Annual Product Review (APR) Support specific to Validation and Change Control as needed.
- Provide support for cleaning and Mfg. Process related deviations and exceptional conditions.
- Perform periodic Equipment Operating Range Assessments.
- The Validation Engineer I will author and provide input to critical Validation systems and conduct validation assessments of equipment, Facilities, and process systems.
- Compile and analyze data, prepare protocols, reports, and make recommendations for changes/or improvements.
- Author Qualification and Validation documents.
- Edit and approve associated documentation.
- Author APR supporting documents.
- Author Periodic Review of validated systems documentation.
- Author Equipment Operating Range Assessment documents.
- Author related Change Controls for systems and processes.
- Bachelor's degree in science or engineering Field of study.
- A minimum requirement of 3 years related pharmaceutical experience- preference for Pharmaceutical Manufacturing Equipment Engineering and Validation experience.
- This role requires technical writing and communication skills, the ability to understand and interpret technical documentation and proficiency with a currently supported version of MS Excel and Word.
- The ability to handle multiple priorities is necessary for success.
- Inputs/Edits Validation and Qualification documentation- serves as resource in the development and approval of documentation.
- The technical approver for protocols and executed qualifications.
- Subject Matter Expert approver for related Change Controls.
Source : Katalyst Healthcares & Life Sciences