Validation Engineer jobs in Butte, MT

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 Supervisor - Mechanical
  • GlaxoSmithKline
  • Hamilton, MT FULL_TIME
  • Site Name: USA - Montana - Hamilton
    Posted Date: Jan 19 2024
    The Validation Supervisor - Mechanical will be primarily accountable to ensure Mechanical qualifications on the entire site and all GMP systems operate in a fully validated state in partnership with the other Validation disciplines.

    This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

    • Provides technical support for utility systems (including purified water systems, WFI, compressed air systems, HVAC, and clean steam systems); process equipment and systems; and provide input necessary to establish technical standards (technical specifications) in compliance with GMP and GSK requirements.
    • Develop and implement templates for standard and specific qualifications (IQ/OQ/PQ protocols) for site equipment and systems to comply with validation policies and regulatory compliance requirements.
    • Define, develop, analyze, and approve specific validation plans or strategies for projects or minor upgrades of site related equipment in their assigned discipline.
    • Ensure compliance readiness for Level 3 audits, Level 4 inspections and provide adequate support to inspected departments prior to and during the audit process.
    • Develop skills of validation staff including technical and regulatory expertise to ensure validation support for all GSK Hamilton projects including IQ, OQ, and PQ protocol development and support of execution.
    • Provide direct technical support to the value streams through the deployment of Subject Matter Experts from the technical team.
    • As a member of the Local MSAT department, be accountable for the Mechanical validation team results.
    • Ensure personal objectives are aligned with site goals and objectives.
    • Drive continuous improvement, new technology and new ideas into Validation ways of working.
    • Supervises the Mechanical Validation team ensuring training, competence, and development are being performed at levels sufficient to support site operations.
    • Manage direct reporting employees time off, hiring, performance management, reward and recognition, and all other applicable HR functions.
    • Assure the design and validation of Hamilton facilities meet the current GSK quality standards in addition to US and European regulatory guidelines.
    • Assure all validation documentation (qualification protocols, reports, SOPs and rationale documents) are issued according to current GSK quality standards in addition to US and European regulatory expectations.
    • Recommend solutions and lead discussions with interested parties to gain a consensus on the qualification of the repair or modification plan detailed in Change Control documents. Provide validation support to the value streams and support functions and participate in the design and specification of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control. Ensure equipment is validated to meet the specific requirements of the process working closely with the process validation team to align strategy.
    • Provide discipline specific IQ, OQ, and PQ protocol development and execution oversight including summary reports and VSRs per approved project schedules.
    • Provide Tier 2 Technical support for Validation related issues or projects within the Hamilton site.
    • Prepare discipline specific presentations for regulatory agencies regarding the validation program, testing philosophy, rationales, and results. Provide technical expertise during regulatory audits including presentations by SMEs and ownership of validation policies and testing philosophies.
    • Support Quality Management System (QMS) implementation within respective area of accountability. In addition, responsible for completing the training on all relevant GQPs, GQMPs and GSOPs.
    • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, standard operating procedures, and industry practice.

    Why you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:

    • Bachelor's Degree in biology, engineering, or life sciences
    • 5 years of experience in Validation in the Vaccines, Pharmaceutical or GMP industry.
    • 1 year(s) of experience in management or supervisory role including matrix environments or managing contractors.

    Preferred Qualifications:

    • Master's Degree in biology, engineering, or life sciences

    #LI-GSK

    #LI-Onsite

    Please visit to learn more about the comprehensive benefits program GSK offers US employees.

    Why Us?

    GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

    GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting site.

     

  • 8 Days Ago

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Field Engineer
  • PCL Construction Services, Inc.
  • Bozeman, MT FULL_TIME
  • The future you want is within reach. At PCL, we build the places where life happens and find camaraderie in the process. We're a community of builders committed to building better communities. That's ...
  • 19 Days Ago

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Project Engineer
  • Baker Concrete Construction, Inc
  • Bozeman, MT FULL_TIME
  • Role: Project Engineer Add Section SHORTDESCRIPTION section. 1 of 4.Section Title: Summary Summary ? Shown on internal and external posting Section content, to edit press enter. Baker Concrete Constru...
  • 22 Days Ago

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Project Engineer
  • North Fork Builders
  • Bozeman, MT FULL_TIME
  • JOB SUMMARY: North Fork Builders is a Bozeman, Montana based general contractor that specializes in thoughtfully designed and strategically executed residential and commercial buildings. We are commit...
  • 23 Days Ago

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Field Engineer
  • Herzog
  • Missoula, MT OTHER
  • Overview Founded in 1969, Herzog is headquartered in St. Joseph, Missouri, with a satellite office in Fort Worth, Texas. Over the course of our 50 year history, Herzog has become a national leader in ...
  • 23 Days Ago

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Staff Engineer
  • Pioneer Technical Services, Inc
  • Butte, MT FULL_TIME
  • Department: Butte Job Status: Fulltime Work Schedule: Monday thru Friday 8-5 unless needed Amount of Travel Required: 10-20% Position Description Pioneer Technical Services is currently looking for an...
  • 23 Days Ago

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0 Validation Engineer jobs found in Butte, MT area

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ISP (Inside Plant) Engineer I
  • Spectrum
  • Butte, MT
  • Job Description Responsible for troubleshooting, support and maintenance of network elements and connections required to...
  • 3/28/2024 12:00:00 AM

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Union Engineer
  • CBRE
  • Butte, MT
  • Union Engineer Job ID 157086 Posted 29-Feb-2024 Service line GWS Segment Role type Full-time Areas of Interest Engineeri...
  • 3/28/2024 12:00:00 AM

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2024 Summer Team Leader
  • Montana Tech
  • Butte, MT
  • 2024 Summer Team Leader Temporary, full-time Duties: Participate in program training and orientation Participate and tra...
  • 3/28/2024 12:00:00 AM

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Telecom Engineer
  • Spectrum
  • Butte, MT
  • Job Description Responsible for troubleshooting, support and maintenance of network elements and connections required to...
  • 3/28/2024 12:00:00 AM

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Cable Engineer
  • Spectrum
  • Butte, MT
  • Job Description Responsible for troubleshooting, support and maintenance of network elements and connections required to...
  • 3/28/2024 12:00:00 AM

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Telecommunications Engineer
  • Spectrum
  • Butte, MT
  • Job Description Responsible for troubleshooting, support and maintenance of network elements and connections required to...
  • 3/28/2024 12:00:00 AM

Butte is the county seat of Silver Bow County, Montana, United States. In 1977, the city and county governments consolidated to form the sole entity of Butte-Silver Bow. The city covers 718 square miles (1,860 km2), and, according to the 2010 census, has a population of approximately 36,400, making it Montana's fifth largest city. It is served by Bert Mooney Airport with airport code BTM. Established in 1864 as a mining camp in the northern Rocky Mountains on the Continental Divide, Butte experienced rapid development in the late-nineteenth century, and was Montana's first major industrial cit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$47,095 to $62,918
Butte, Montana area prices
were up 3.1% from a year ago

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