Junior Engineer; Validation

Hauppauge, NY (http://maps.google.com/maps?q=145+Oser+Avenue+Hauppauge+NY+USA+11788)

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Description

Position Summary:

The Junior Validation Engineer (Technical Services) is responsible for performing process validation, cleaning validation and equipment validation activities for solid dosage pharmaceuticals.

Responsibilities:Responsibilities include, but are not limited to:

• Create and/or approve validation documents to support manufacturing, packaging, and cleaning validation requirements.

• Train operations and quality teams on validation protocols as needed.

• Collect validation samples and deliver to appropriate laboratory area/personnel for testing.

• Perform review of the executed protocol, validation batch records, test reports for accuracy and Good Documentation Practices.

• Compile validation data, perform trend analysis and develop validation summary report.

• Develop and coordinate approval of validation risk assessment memo.

• Maintain and periodically update master database with validation activities and the equipment qualification list in Electronic Document Management system.

• Assist with change controls, by carrying out investigations for process deviations and corrective actions as needed.

• Provide necessary support to operations and quality teams during the execution of process and cleaning validation activities.

• Develop and execute equipment qualification protocols (IQ/QO/PQ) and generate qualification summary report, if required.

• Maintain the annual calibration program for critical process instruments (temperature controllers, pressure gauges, data loggers, etc.) and work with external vendors to ensure timely completion of calibration activities, if required.

• Maintain the annual program and record keeping of documentation for compressed air testing, clean room certifications, HEPA filter testing, if required.

• Assist in assessment for gap analysis, modifications and process enhancements to improve efficiency and quality.

• Coordinate with other departments, as needed for engineering and validation projects.

• Other responsibilities as assigned by Senior Management.

Requirements

Education and Experience:

• Bachelor’s degree in engineering or related field.

• Master’s degree in engineering or related field.

• Minimum 2 years work experience in Pharmaceutical, Food or Cosmetic manufacturing industry in lieu of Master’s degree.

• Experience with pharmaceutical manufacturing and packaging equipment / process.

Skills, Knowledge and Abilities:

• Excellent oral and written communications skills.

• Knowledge of US FDA Good Manufacturing Practices (21 CFR).

• Strong technical writing skills.

• Ability to prioritize and multitask in a fast-paced environment.

• Ability to interact with all levels of personnel.

Physical Demands:

• Required to use hands to operate computer controls.

• Specific vision abilities required include close vision, ability to focus.

• While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear or walk for long periods. The employee may lift and/or move up to 50 lbs.

Work Environment:

• Work environment in production operations facilities include proximity to heavy machinery and pharmaceutical powders.

• Potential to move between production operations sites/areas to complete job functions.

• Hours/Travel maybe subject to changed based on management/company discretion.

Supervisory Responsibilities:

• None

Pay Range:

$60,000 - $75,000 per year