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



Employer Name: Prowess IT Solutions LLC SpiderID: 10267304
Location: Hauppauge, New York Date Posted: 3/25/2021
Wage: $41.35/hr Category: Healthcare
Job Code:
Number Of Openings: 1

Job Description:
Validation Engineer needed to perform the following duties :

• Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.
• Generate various technical documents such as protocols for method validation, Standard operating procedures (SOP’s), Specifications and reports.
• Generate change control, CAPA, and perform investigation for process deviations.
• Responsible for activities for cleaning verification and process validation and gap analysis as per FDA and ICH requirements.
• Perform calibrations for pharmaceutical equipment’s such as analytical instrument and manufacturing instruments.
• Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, 503B, ICH guideline knowledge.
• Ability to interpret data from various sources such as USP NF, Protocols etc.
• Perform various analytical testing using analytical instruments such as Assays, Content uniformity.
• Responsible for performing stability studies, Cleaning method studies, Raw material and packaging material testing.
• Perform Calibrations and qualification studies for Analytical instruments.
• Ability for interpretation of data generated by various developmental analytical tests including Dissolution, Blend Uniformity, Assay, HPLC, Particle size, Spectroscopy, etc.
• Write, execute and review complex protocols and coordinate validation activities from another department.
• Train other validation personnel.


Job Requirements:
Bachelor’s Degree required in Chemistry or Pharmacy or Pharmaceuticals Engineering


Job Criteria:
Start Date: May 1, 2021
Position Type: Full-Time Permanent
Years of Experience Required: 3
Education Required: Bachelors
Overnight Travel:
Vacation Time:


Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave

Contact Information:
Contact Name: Sridevi Gandapodivasu Company Type: Employer
Company: PROWESS IT SOLUTIONS LLC Phone: 7184879837
Street: 2 Brier Hill Court, 2B Building F Fax:
City: East Brunswick
State: New Jersey
Zip: 08816
Web Site: https://www.prowessitsolutions.com

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