- 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).
-
Validation Engineer
2 days ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
-
Validation Engineer
3 weeks ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
-
Validation Engineer/Specialist
12 hours ago
IPS-Integrated Project Services, LLC Somerset, United StatesJob Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located ...
-
Sr Associate, Validation Engineer
4 weeks ago
Prostaff Solutions LLC New Brunswick, United StatesJob Description · Job 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 pharm ...
-
Validation Engineer
12 hours ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesRoles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...
-
Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesRoles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...
-
Facility Validation Engineer
3 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepare ...
-
Senior Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesMultiple Positions and systems are available: SDMS/Labx/Veeva RIM/SDMS/ValGenesis/Labware LIMS Perform "Data Integrity" related- risk assessments, · Deviation investigations suggest implementing remediations in CGMP operations. · Performs Data Integrity compliance/impact assessm ...
-
Validation Engineer
2 weeks ago
Innova Solutions Summit, United StatesInnova Solutions is immediately hiring for a Validation Engineer · Position type: Full-time Contract · Duration: 06 Months · Location: Summit, NJ Onsite) · As a Validation Engineer, you will: · The Equipment Validation Engineer supports the successful implementation of various pr ...
-
Validation Engineer
1 week ago
Hyper Recruitment Solutions New York, United StatesValidation Engineer · On-site - New Jersey (Commutable from New York) · Up to $115,000 depending on experience · Sponsorship transfers available for H1B VISA holders · Our client is an established manufacturer who are expanding their US Validation Department. · With exciting pro ...
-
Validation Engineer
3 weeks ago
Acara Solutions, An Aleron Company New Jersey, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
-
Validation Engineer
4 weeks ago
Pyramid Consulting New York, United StatesImmediate need for a talented · Validation Engineer - I (Assistant) . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · West Point, PA(Onsite) . Please review the job description below and contact me ASAP if you are interested. · Job ...
-
Validation Engineer
2 days ago
Katalyst Healthcares & Life Sciences New Jersey, United States ContractResponsibilities: · Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core ...
-
Validation Engineer,packaging
3 weeks ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesRoles&Responsibilities: · Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment that ...
-
Validation Engineer
5 hours ago
Katalyst HealthCares & Life Sciences Jersey City, United StatesResponsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (G ...
-
Validation Engineer
1 day ago
Kelith Group Inc San Francisco, United States PermanentKelith Group Inc has openings for the positions of Validation Engineer with master's degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of exp in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for vali ...
-
Validation Engineer
3 weeks ago
System One Holdings, LLC Summit, United StatesJob Title: Validation Engineer · Location: Summit, NJ · Type: Contract · Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change managemen ...
-
Validation Engineer
1 week ago
On-Board Companies Summit, United StatesOn-Board Services is hiring a Validation Engineer in Summit, NJ · For immediate consideration please send your resume to · Subject Line: Position Title and State you are Located · About Us: · On-Board Services, Incorporated is an on-site contract service provider for a local man ...
-
Validation Engineer
1 day ago
Innova Solutions Summit, United StatesInnova Solutions is immediately hiring for a Validation Engineer · Position type: Full-time Contract · Duration: 06 Months · Location: Summit, NJ Onsite) · As a Validation Engineer, you will: · The Equipment Validation Engineer supports the successful implementation of vario ...
-
Validation Engineer
2 weeks ago
Ascent Services Group Summit, United StatesInnova Solutions is immediately hiring for a Validation Engineer · Position type: Full-time Contract · Duration: 06 Months · Location: Summit, NJ Onsite) · As a Validation Engineer , you will: · The Equipment Validation Engineer supports the successful implementation of vario ...
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 aSr. 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:
Requirements:
Excellent communication:
verbal, written and presentation skills
Please visit us at to explore all opportunities.
#IND2
#ps
#J-18808-Ljbffr