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| Employer Name: Bactolac Pharmaceutical, Inc. |
SpiderID: 10448229 |
| Location: Hauppauge, New York |
Date Posted: 4/30/2021 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
Validation Engineer is needed to perform the following duties :
• Analyze data, prepare/revise process validation protocols and validation summary reports under guidance from our Director of Production/Engineering;
• Work closely under the direction of engineering manager and follow engineering principles/instructions to develop, implement and monitor validation metrics including developing/implementing new and custom validation protocols/metrics for each department to ensure accurate outcomes;
• Write process and/or equipment protocols as per guidelines for formulation, labeling, filling and packaging for all products including support systems – will be reviewed by engineering manager and approved for use;
• Develop cleaning validation protocols, prepare cleaning assessments and reports as instructed for review and approval by our engineering manager;
• Assist engineering manager to investigate and troubleshoot processing issues and provide written documentation of findings & recommendations for review/approval by engineering manager;
• Perform physical testing of finished products including tablet weight analysis using advanced electronic equipment;
• Assist engineering manager by following guidelines/instructions to ensure compliance with cGMPs & other regulatory requirements and to ensure continuous validation maintenance for facility and process through change control program;
• Coordinate with other departments to ensure effective validation planning and to execute specific validation protocols as per master validation plan;
• Approximately 85% of the time will be spent in analyzing data, developing and implementing validation protocols, monitoring validation processes, investigating/troubleshooting process issues, developing cleaning validation protocols etc. by following established guidelines and under supervision of our engineering manager. Approximately 15% of the time will involve preparing validation reports, ensuring cGMP/SOPs/regulatory compliance, maintaining validation metrics and preparing associated reports for review and approval by our engineering manager. etc
Bachelor's Degree is required in Mechanical Engineering or Biomedical Engineeing
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Bactolac Pharmaceutical, Inc. |
Company Type: |
| Company: Bactolac Pharmaceutical, Inc. |
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| City: HAUPPAUGE |
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| State: New York |
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| Zip: 11788 |
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