Validation Engineer Position Available In Mercer, New Jersey

Validation Engineer Job Employer Name:

ND Global Consulting Services Inc

SpiderID:

13772889

Location:

Hightstown, New Jersey

Date Posted:

6/19/2024

Wage:

$101000

Category:

Engineering

Job Code:

Number Of Openings:

1

Job Description:

Validation Engineer is needed to perform the following duties:

• Drafting the qualification protocols and qualification reports for process equipment and facilities for Biopharmaceutical facilities, injectable and / or oral solid dosage facilities.
• Ensuring that all facilities, utilities, equipment, computer systems and processes are qualified and validated as required per current regulations.
• Drafting, reviewing, and approves commissioning, qualification, and validation deliverables (URS, FAT, SAT, TOP, DQ, IQ, OQ, PQ, PPQ, CSV and PV (cleaning, sterilization) for facilities, utilities, equipment, computerized systems, Laboratory Instruments, and processes related to compounding of sterile and non-sterile injectables.
• Working on reviewing and approving Exceptional Conditions or Deviations generated during commissioning and qualification (CQV) execution.
• Working on completing change control impact assessments for new systems or changes to existing systems and processes.
• Performing continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness, improving manufacturing efficiency and output performance.
• Working on machinery such as clean steam generator, autoclave, depyrogenation oven, solids compounding equipment and lyophilizer for production/ operational support.
• Supporting in developing and performing lyophilization, and sterilization cycle development and develop cleaning validation and disinfectant studies for the sterile products.
• Working on Code verification test protocols for automated systems for CIP’s and SIPs, Chromatographic skids, Manufacturing skids, HPLC, GC and other manufacturing equipment.
• Assisting with resolving issues arisen from internal quality assessments as per Internal Society for Pharmaceutical Engineering (ISPE) guidelines and preparing appropriate responses and corrective action resolutions
• Prepare Master Plan for CIP & SIP, Validation Protocol and Final report in compliance with 21 CFR guidelines, regulatory specifications, and FDA. Apply Good Documentation Practices in the execution of protocols, calibrations procedures and other cGMP documents.
• Drafting standard operating procedures (SOPs) and support QA audits of existing operating procedures to ensure the compliance with company current regulatory requirements.

Responsible for developing and executing on validation plans according to approved procedures.

Job Requirements:

Bachelor’s Degree is required in Pharmaceutical Science or Pharmaceutical Engineering or Pharmacy .

Job Criteria:

Start Date:

07/01/2024

Position Type:

Full-Time Permanent

Years of Experience Required:

1

Education Required:

Masters

Overnight Travel:

Vacation Time:

Job Benefits:

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

Contact Name:

Rashmi Kumari

Company Type:

Company:

ND Global Consulting Services Inc City:

McKinney State:

Texas Zip:

75070