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Onsite in New Berlin, NY
Company Summary: Our client is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world.
What You Can Expect To Be Doing
• 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.
• Report directly to the Director Operations & Pharmaceutical Technology.
• 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
• 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
What You Will Bring To The Table
• 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 a proficiency with a currently supported version of MS Excel and Word. The ability to handle multiple priorities is necessary for success.
Please email Laura@ScientificSearch.com to learn more about this fantastic opportunity!
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