- Prepare and execute URS, IQ/OQ/PQ protocols and write summary reports for production and packaging equipment, utilities equipment like HVAC, Air compressor, Boiler, Purified water system, area qualification, and temperature mapping study of warehouse and storage area.
- Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
- To coordinate commissioning activities for engineering projects of new area and equipment
- To review and execute PPV (Periodical Performance Verification) of equipment
- To develop calibration plan for new equipment
- Prepare and train for the Set up/Operational/Cleaning/Maintenance SOPs
- Identify, investigate and troubleshoot deviations for multiple concurrent projects
- Preparation of Personnel flow, Incoming and finished material flow, as well as Waste flow in the facility
- To assist in preparation of internal audit, FDA, DEA, and other agency audit responses
- Prepare, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents
- Minimum of Bachelor's degree in Engineering or Science related field
- Minimum of eight (8) years of experience within the pharmaceutical industry, preferably oral solid dose
- Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as R&D
- Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS, VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPS, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan
- Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents
- A self-starter with hands-on approach and a can-do attitude
- Excellent project management and problem solving skill
- Must be capable of bending and lifting, moving and/or carrying up to 50 lbs
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework for Reference for Languages (CEFR).
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Sr Associate, Validation Engineer - New Brunswick, United States - Prostaff Solutions LLC
Description
Are you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a Sr.
Direct Hire
Pay Rate:
DoE
Job Summary:
The Sr Associate, Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements
Area of Responsibility:
Excellent communication:
verbal, written and presentation skills
Please visit us at to explore all opportunities.
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