No more applications are being accepted for this job
- 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
- 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).
Sr Associate, Validation Engineer - New Brunswick, United States - Prostaff Solutions LLC
Description
Job DescriptionJob Description Are you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a
Sr. Associate, Validation Engineer
to join their
New Brunswick, New Jersey team . Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing of solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
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:
SOPs
Requirements:
Excellent communication:
verbal, written and presentation skills
Please visit us at
to explore all opportunities.
#IND2
#ps Company Description Prostaff Solutions is committed to all aspects of staffing services
We offer comprehensive best-practices for our clients and employees.
Our Vision:
ProStaff Solutions strives to be the premier employment solutions provider to every community we serve.
Our Mission:
Our mission is to bring the right people to the right job every time. Accomplishing this, we better people's lives and increase our customers and employees success.
Our Values :
Our Pledge of Integrity
Our name is the most important thing we own. To us, it is more than an identity. It is also how we act. It is both the foundation and the heart of our business.
Because our success depends on our personal integrity and honesty, we work hard. We also reward hard work.
We believe great things happen when we listen to each other, and that is why our doors are always open.
We also strive to strengthen our communities by example in leadership, and by donations of time and resources.Company Description
Prostaff Solutions is committed to all aspects of staffing services\rWe offer comprehensive best-practices for our clients and employees
\r\r
Our Vision:
\rProStaff Solutions strives to be the premier employment solutions provider to every community we serve
\r\r
Our Mission:
\rOur mission is to bring the right people to the right job every time. Accomplishing this, we better people's lives and increase our customers and employees success.
\r\r
Our Values :
\rOur Pledge of Integrity\rOur name is the most important thing we own. To us, it is more than an identity. It is also how we act. It is both the foundation and the heart of our business.\rBecause our success depends on our personal integrity and honesty, we work hard. We also reward hard work.
We believe great things happen when we listen to each other, and that is why our doors are always open.
We also strive to strengthen our communities by example in leadership, and by donations of time and resources.#J-18808-Ljbffr