Validation Engineer job Hauppauge New York
Validation Engineer  job Hauppauge New York
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Validation Engineer Job

Employer Name: Bactolac Pharmaceutical, Inc. SpiderID: 10448229
Location: Hauppauge, New York Date Posted: 4/30/2021
Wage: Category: Medical/Health
Job Code:

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.
State: New York
Zip: 11788

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