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Validation Engineer
1 week 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 ...
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Validation Engineer/Specialist
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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 ...
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Validation Engineer
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Validation Engineer
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Senior Validation Engineer
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Senior Validation Engineer
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Validation Engineer
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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 ...
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Validation Engineer
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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 ...
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Validation Engineer
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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 ...
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Validation Engineer
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Validation Engineer
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Premier Life Sciences LLC New York, United StatesNot For C2C Candidates Please do not apply even not enquire · Job Title: CQV Validation Engineer · Location: Countrywide USA · Contract Duration: 12+ months · Pay: Negotiable on w2 without any benefits · Responsibilities: · Authoring, editing, and executing technical commission ...
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Validation Engineer
1 week 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 ...
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Validation Engineer
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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 ...
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Validation Engineer
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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 ...
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Validation Engineer
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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 ...
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Validation Engineer
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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 ...
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Validation Engineer
1 week ago
Mindlance Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. T ...
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Validation Engineer
2 weeks 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 ...
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Validation Engineer
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Cynet Systems Summit, United StatesJob Description: · Pay Range: $79hr - $81hr · Responsibilities: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. · The incumben ...
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Validation Engineer
6 days ago
Axelon Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. Th ...
Facility Validation Engineer - New Brunswick, United States - Kaztronix
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Description
Facilities Validation EngineerNo 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 and execute IQ / OQ / PQ protocols and write summary reports for production/packaging equipment, utilities (Temperature mapping study, Stability Chamber , HVAC, Air compressor, Boiler, Purified water system) and process area etc.
Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
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
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.
Manufacturing / Production environment
Environmental related to manufacturing/production environments:
Noise:
Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes:
Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors:
Unpleasant smells.
Gases:
Examples include carbon monoxide and ozone.
Dust:
Airborne particles of any kind, such as textile dust, wood, and silica.
Hazards:
Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.
Education and ExperienceMinimum of five (5) years in Pharmaceutical, preferably Oral Solid Dosage.
Bachelor's Degree in Engineering or Science related field.
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 research and development.
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.Demonstrated excellent communication:
verbal, written and presentation skills.
A self-starter with a hands-on approach and a can-do attitude.
A team building champion driving innovative cross functional synergies.
Excellent project management and problem solving skill
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 of Reference for Languages (CEFR).
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