Validation Engineer jobs in Gastonia, NC

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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Validation Manager
  • Exela Pharma Sciences
  • Lenoir, NC FULL_TIME
  • Position Summary:

    Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of new products, as needed.

    Job Responsibilities: 

    • Plan, perform and coordinate validation projects to ensure timely completion
    • Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents
    • Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations 
    • Analyze data to provide recommendations for improvements in the manufacturing process and equipment 
    • Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation
    • Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation and calibration
    • Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts
    • Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports
    • Assist with the technical assessment and resolution of deviances and variances that occur during production or validation
    • Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits
    • Ensure site/system validation program meets FDA, ISO and EU requirements
    • Collaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvement
    • Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
    • Provide updates to Senior Management on site validation status activities
    • Provide validation training to staff on validation protocols and standard operating procedures
    • Support investigations and implementation of CAPAs, as needed
    • Perform any other duties assigned 

    Required Skills:

    • Must have exceptionally strong communication, interpersonal and project management skills
    • Ability to multi‐task and methodically manage projects in a fast‐paced manufacturing environment
    • Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines
    • Ability to manage consultants and set expectations for the quality and timeliness of their deliverables

    Education and Experience Requirements: 

    • Bachelors, Masters, or Ph.D. in Biochemistry, Biology, or related science field
    • Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
    • Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practice
    • Demonstrated history of team management and effecting cross‐functional change with strong analytical problem solving and interpersonal skills
    • Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience
    • At least 8 years’ experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA‐regulated environment
    • A minimum of 4 years’ experience with aseptic and terminally sterilized products

    EOE, including disability/vets. 

  • 11 Days Ago

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Director, Validation
  • Exela Pharma Sciences
  • Lenoir, NC FULL_TIME
  • Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products in a fast-growing progressiv...
  • 16 Days Ago

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Engineer
  • Bernhardt Furniture Company
  • Lenoir, NC FULL_TIME
  • Engineer Bernhardt Design Plant 3 1502 Morganton Blvd Lenoir, NC 28645 Ph: 828-759-6398 Job Requirements: Associates or Bachelor’s degree in Engineering Job Description: Acts as a resource for develop...
  • Just Posted

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Operating Engineer
  • JLL
  • Kings Mountain, NC FULL_TIME
  • What this job involves - The Operating Engineer performs various skilled and semi-skilled tasks in the installation, repair, maintenance and operation of mechanical, electrical, and environmental cont...
  • 19 Days Ago

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Plant Engineer
  • Impact Solutions Inc
  • Morganton, NC FULL_TIME
  • JOB DESCRIPTION The Plant Engineer will be an integral part of the engineering and leadership teams, driving plant activity, continuous improvement, and process optimization. Looking for a change agen...
  • 20 Days Ago

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Industrial Engineer
  • HSM Solutions
  • Hickory, NC FULL_TIME
  • Overview As an Industrial Engineer working in manufacturing, your primary responsibility is to optimize and streamline production processes to enhance efficiency, reduce costs, and improve overall pro...
  • 22 Days Ago

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0 Validation Engineer jobs found in Gastonia, NC area

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Industrial Hygiene Technician
  • Synerfac
  • Charlotte, NC
  • Details: Position - Industrial Hygiene Technician Location - Charlotte, NC Company - Engineering Firm Description - This...
  • 3/28/2024 12:00:00 AM

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Packaging Engineer
  • The Judge Group
  • Charlotte, NC
  • A global manufacturing client is searching for a Packaging Engineer in the Greensboro, NC area.RESPONSIBILITIES: Analyze...
  • 3/28/2024 12:00:00 AM

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Electrical / Electronic Field Service Technician
  • Critical Power Services, Inc.
  • Charlotte, NC
  • Job Description Job Description Electrical/Electronic Field Service Technician The Electrical Field Service Technician i...
  • 3/27/2024 12:00:00 AM

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Professional Services Systems Engineer
  • Complete Network
  • Charlotte, NC
  • Job Description Job Description Complete Network is seeking a highly skilled and motivated Senior Systems Engineer to jo...
  • 3/27/2024 12:00:00 AM

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Reliability Automation Control Engineer
  • SHL Medical
  • Charlotte, NC
  • SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delive...
  • 3/25/2024 12:00:00 AM

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Senior R&D Engineer - Medical Devices
  • Medical Murray
  • Charlotte, NC
  • Job Description Job Description The wage range for this position is $95,000 to $160,000. Compensation decisions are depe...
  • 3/25/2024 12:00:00 AM

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Forensic Engineer, PE (Civil/Structural)
  • STEPHENS Engineering
  • Charlotte, NC
  • Job Description Job Description We are growing!! Would you like to work for a growing company where your efforts are ack...
  • 3/25/2024 12:00:00 AM

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Calibration Technician - Level I
  • ETI Precision
  • Charlotte, NC
  • Job Description Job Description ETI Precision is looking for a talented calibration technician to join its team in Charl...
  • 3/24/2024 12:00:00 AM

Gastonia is the largest city in and county seat of Gaston County, North Carolina, United States. It is also the second largest satellite city of the Charlotte area, behind Concord. The population was 71,741 at the 2010 Census. In 2016, the population had increased to 75,536. Gastonia is the 13th largest city in North Carolina. It is part of the Charlotte metropolitan area, officially designated the Charlotte Metropolitan Statistical Area (MSA). Gastonia has experienced steady growth, with a population increase between 2000 and 2010 of nearly 8.2%, according to the U.S. Census Bureau. According...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$54,702 to $73,080
Gastonia, North Carolina area prices
were up 1.5% from a year ago

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