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 is responsible for performing qualification and engineering activities for solid dosage pharmaceutical manufacturing and packaging equipment, facilities, and critical utility systems.

Responsibilities:Responsibilities include, but are not limited to:

• Prepare and execute qualification activities (DQ, FAT, IQ, OQ, PQ) protocols.

• Read, understand, verify, and develop P&ID, engineering layout, engineering drawings and engineering documents.

• Develop strategy for Packaging engineering studies. Prepare and execute packaging engineering studies protocol, develop report and assist in enhancing packaging process efficiencies.

• Prepare, review, and maintain master database of packaging set-up sheets containing critical machine specification in electronic document management system.

• Assign Asset number to new equipment/utility system and maintain master asset list/qualification database in electronic document management system.

• Prepare and execute qualification and temperature mapping studies for warehouse storage area and special temperature-controlled areas.

• 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.

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

• Prepare clear SOPs and assist in providing personnel training for set-up, operation and maintenance of manufacturing and packaging equipment, utility systems and qualifications.

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

• Organize and maintain documents for equipment including manuals, protocols, drawings and calibrations.

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

• 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, packaging, and utility equipment (HVAC, water systems, compressed air systems) preferred.

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