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Validation Engineer/Specialist
1 week 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 ...
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Validation Engineer
1 week 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 ...
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Validation Engineer
3 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 ...
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Facility Validation Engineer
4 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 ...
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Senior Validation Engineer
4 days ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesResponsibilities & Requirements: Multiple 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 ...
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Senior Validation Engineer
3 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 ...
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Validation Engineer
4 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 ...
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Validation Engineer
2 weeks 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 ...
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Validation Engineer
3 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 ...
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Validation Engineer
3 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 ...
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Validation Engineer
6 days ago
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
1 week 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 ...
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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
1 day ago
Piper Companies Trenton, United StatesPiper Health and Sciences is actively seeking a Senior Validation Engineer to join a large global biotechnology company in the greater Trenton NJ area. · Responsibilities for Senior Validation Engineer: · Commissioning, qualification, and validation of biopharmaceutical manufac ...
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Validation Engineer
1 week 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 ...
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Validation Engineer
3 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 ...
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Validation Engineer
1 week 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 ...
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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 days ago
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 ...
Validation Engineer - New Brunswick, United States - Sun Pharmaceutical Industries
Description
Job 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.
Area of Responsibility:
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.
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.
To write investigation and finished on timely manner.
To create and closed all change controls, CAPA and investigation on timely manner.
To create sops for facilities and utilities.
Monitor work order status and make sure completed correctly and filed, follow up with maintenance mechanics to close open work orders in timely manner.
Education and Qualifications:
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
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job.
Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
EEO Notice:
We provide equal employment opportunities for all current employees and applicants for employment.
This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency andSearch Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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