Validation Engineer jobs in Utica, NY

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Process Validation Scientist
  • AGC Biologics
  • Copenhagen, NY FULL_TIME
  • Are you ready to employ your knowledge and experience in order to improve patients’ lives? Would you like to play a crucial role in ensuring adequate process validation strategy is applied in biopharmaceutical manufacturing? If yes, welcome. You are on the right page!
    We, Process Validation Department, work with portfolio of diverse projects to provide necessary knowledge and documentation to our customers and support their journey through all phases of a process validation. We work with trust, knowledge, ingenuity, accountability and team spirit sprinkled with good sense of humor and laidback atmosphere.  

    What you can expect in a Process Validation Scientist role in AGC Biologics:

    • Lead, coordinate and oversee validation activities for drug substance manufacturing throughout the process validation lifecycle.  
    • Prepare risk assessments (extractable and leachables, nitrosamine, elemental impurities)
    • Write process mix and hold validation plans, protocols and reports in a timely manner and according to project requirements.
    • Be responsible for CPV program for our commercial projects.
    • Use scientific knowledge to analyze and interpret data. Take timely and appropriate action based on the data output, project needs and internal procedures.
    • You will represent our department effectively and professionally in interactions with internal and external stakeholders.
    • Represent the department in audits and regulatory inspections.
    • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory guidelines.
    • Assess impacts on validated processes and propose mitigating actions, if required. 

    You:

    • Degree in biological sciences, pharmacy, engineering, or related fields.
    • At least 1 year of relevant experience in process validation.
    • Familiar with cGMP, EMA, FDA, and ICH guidelines for process validation.
    • At least 2 years of relevant experience in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting.
    • A fast learner, proactive professional, with positive mindset to work with multidisciplinary teams and find solutions to challenges.
    • Able to work independently toward defined goal.
    • Strong technical writing and presentation skills.
    • Experience with SAS JMP and data handling is advantage.

    The company language is English, so adequate written and spoken English communication skills are required.

     

    Want to keep posted about our growth and to learn more about our company?

    We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

     

    AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

     

    Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

  • 1 Month Ago

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IT Validation Scientist
  • AGC Biologics
  • Copenhagen, NY FULL_TIME
  • Are you ready for a unique opportunity to shape the validation/qualification direction for computerized software in AGC Biologics? Do you have a quality mindset and are you eager to contribute your en...
  • 1 Month Ago

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Facility & Equipment Validation Scientist
  • AGC Biologics
  • Copenhagen, NY FULL_TIME
  • Are you motivated by finding ways through the jungle of GMP (Current Good Manufacturing Practice), Validation/qualification projects & securing delivery of vital medicine to patients? Would you like t...
  • 4 Months Ago

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IT Validation Manager - International Vaccineproducent med hovedkontor i København
  • ARNVIND GROUP
  • Copenhagen, NY FULL_TIME
  • EXO ARNVIND søger en IT Validation Manager til International Vaccineproducent - med hovedkontor i København. Er du klar til at anvende dine kompetencer inden for validering og kvalitetskontrol? Ønsker...
  • 16 Days Ago

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Systems Engineer
  • Oneida Technical Solutions
  • Oneida, NY FULL_TIME
  • Oneida Technical Solutions, LLC (OTS) has a rich history of providing IT support and associated services in highly complex, highly regulated, highly secure environments, including the U.S. Department ...
  • 19 Days Ago

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Process Engineer
  • Precision Castparts Corp. (PCC)
  • New Hartford, NY FULL_TIME
  • Country 1 United States of America State / County 1 New York City 1 New Hartford Division 1 Metals Company 1 New Hartford/Dunkirk Function 1 Engineering Workplace Type 1 On-Site Position type 1 Full T...
  • 19 Days Ago

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0 Validation Engineer jobs found in Utica, NY area

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Diesel Mechanic Technician
  • Ryder System
  • MARCY, NY
  • Position Description Immediately hiring a Permanent Full Time Experienced Mid-Level Diesel Technician to support our Tru...
  • 3/28/2024 12:00:00 AM

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Process Engineer
  • 21st Century Staffing,LLC
  • New Hartford, NY
  • Job Description Job Description Job Description Administering to daily technical issues; understanding the product end u...
  • 3/28/2024 12:00:00 AM

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Process Engineering Manager
  • Danfoss
  • Utica, NY
  • Job Description Process Engineering Manager is responsible for leading a team of manufacturing engineers and technicians...
  • 3/28/2024 12:00:00 AM

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Service Technician
  • Northland Telephone
  • Utica, NY
  • Job Description Job Description JOB DESCRIPTION JOB TITLE: Service Technician STATUS: Non-Exempt DEPARTMENT: Operations ...
  • 3/27/2024 12:00:00 AM

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Field Service Engineer, Semiconductor Equipment
  • SUSS MicroTec Inc.
  • Marcy, NY
  • Job Description Job Description SUSS MicroTec Inc. is seeking a Field Service Engineer for Semiconductor Equipment. Resp...
  • 3/27/2024 12:00:00 AM

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Semiconductor Field Service Engineer - Entry and Junior Level
  • Express Employment Professionals
  • Marcy, NY
  • Job Description Job Description Engineering / Field Service Techs – Entry and Junior Level Our client is a large, intern...
  • 3/26/2024 12:00:00 AM

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Field Service Engineer
  • Screen SPE USA
  • Utica, NY
  • Job Description Job Description SCREEN SPE USA (SEUS) was established in 1987 in Sunnyvale, California. SEUS is the sale...
  • 3/25/2024 12:00:00 AM

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Cannabis Operations Post Process Technician
  • Verona Collective
  • Verona, NY
  • As a Post Process Tech, you will ensure products are packaged on time and assist in the trim, bucking, and grinding proc...
  • 3/25/2024 12:00:00 AM

Utica (/ˈjuːtɪkə/ (listen)) is a city in the Mohawk Valley and the county seat of Oneida County, New York, United States. The tenth-most-populous city in New York, its population was 62,235 in the 2010 U.S. census. Located on the Mohawk River at the foot of the Adirondack Mountains, Utica is approximately 95 miles (153 kilometers) northwest of Albany, 55 mi (89 km) east of Syracuse and 240 miles (386 kilometers) northwest of New York City . Utica and the nearby city of Rome anchor the Utica–Rome Metropolitan Statistical Area, which comprises all of Oneida and Herkimer counties. Formerly a rive...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$54,295 to $72,537
Utica, New York area prices
were up 1.5% from a year ago

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