Scientist - Biotech jobs in Durham, NC

Scientist - Biotech develop and conduct basic and applied research projects. Utilize advanced technologies to study biological, molecular and chemical processes. Being a Scientist - Biotech synthesize and analyze DNA, proteins and other molecules to develop new drugs, medical protocols, and products. Prepare technical papers and reports on findings. Additionally, Scientist - Biotech requires a PhD in area of specialty. Typically reports to a supervisor or manager. To be a Scientist - Biotech typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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Validation Engineer
  • Sequoia Biotech
  • Raleigh, NC FULL_TIME
  • Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatory affairs and validation at a variety of clients within the biotechnology industry.

    Sequoia's hands-on consultants provide technical knowledge and relevant life science experience to establish best practices in manufacturing, pharmaceutical and medical device companies. We are helping to produce better, faster and more economically priced medicines and medical devices around the world.

    Validation Engineer

    Position Overview: We are looking for a talented and detail-oriented Validation Engineer to execute and oversee validation activities within our clients’ pharmaceutical manufacturing facilities. The Validation Engineer will be responsible for planning, executing, and documenting validation protocols, ensuring that equipment, processes, and systems operate efficiently, reliably, and in compliance with regulatory requirements.

    Responsibilities:

    1. Validation Planning:
      • Develop validation master plans and protocols for equipment, processes, and systems used in pharmaceutical manufacturing.
      • Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.
    2. Validation Execution:
      • Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment and processes.
      • Conduct risk assessments and validation studies to identify potential issues and implement corrective and preventive actions.
    3. Documentation and Reporting:
      • Maintain accurate and detailed validation documentation, ensuring compliance with regulatory standards and internal procedures.
      • Prepare validation reports summarizing findings, conclusions, and recommendations for stakeholders and regulatory submissions.
    4. Change Control and Impact Assessment:
      • Assess the impact of proposed changes to equipment, processes, or systems on validation status.
      • Manage change control processes, ensuring that changes are properly evaluated, documented, and validated to maintain compliance.
    5. Collaboration and Training:
      • Collaborate with engineering, quality, and production teams to implement validation requirements for new equipment and processes.
      • Provide training and guidance to staff on validation procedures, documentation practices, and regulatory compliance requirements.
    6. Continuous Improvement:
      • Stay updated on industry trends, regulatory guidelines, and best practices related to validation activities.
      • Identify opportunities for process improvements and implement best practices to enhance validation efficiency and effectiveness.

     

    Qualifications:

    • Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.
    • Experience in commissioning, qualification, and validation in a regulated industry
    • Hands-on startup, commissioning, and qualification experience with one or more of the following systems: HVAC, Water-for-Injection, Autoclaves, Glasswashers, CIP, Bioreactors, Chromatography systems, Filtration systems
    • Strong project management skills, including the ability to manage multiple projects simultaneously.
    • Excellent problem-solving abilities and attention to detail.
    • Effective communication skills and ability to work collaboratively in a team-oriented environment.

     

    Sequoia offers a comprehensive suite of benefits including medical, dental, vision coverage, 401k, and company paid life-insurance.

    Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. Unfortunately, Sequoia is unable to provide any visa sponsorship at this time.

    All your information will be kept confidential according to EEO guidelines.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

  • 22 Days Ago

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Facilities Engineer
  • Sequoia Biotech
  • Raleigh, NC FULL_TIME
  • Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulato...
  • 22 Days Ago

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Senior Project Manager
  • Sequoia Biotech
  • Raleigh, NC FULL_TIME
  • Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulato...
  • 24 Days Ago

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Engineer
  • PSC Biotech
  • Durham, NC FULL_TIME
  • PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applica...
  • 5 Days Ago

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Project Engineer
  • Sequoia Biotech
  • Raleigh, NC FULL_TIME
  • Job Description Seeking a Project Engineer to help management, execution, and day to day support of the Corrective Maintenance (CM) and Preventative Maintenance (PM) Program for critical (GxP) and non...
  • 2 Months Ago

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Biotech Developer Lead
  • Syngenta
  • Durham, NC FULL_TIME
  • In our quest to harness the potential of plants to feed the world, we seek an experienced Bioinformatics Developer to join our Seeds R&D team a Technical Lead Developer. In this capacity, you will be ...
  • Just Posted

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0 Scientist - Biotech jobs found in Durham, NC area

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Scientist, Chromatography
  • Tune Therapeutics
  • Durham, NC
  • Tune Therapeutics is a cutting-edge biotechnology company founded by world-class leaders in epigenome editing. At Tune, ...
  • 3/28/2024 12:00:00 AM

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Scientist
  • The Fountain Group
  • Durham, NC
  • Job Description Job Description Overview: · The role is primarily lab-based, supporting the inhalation product developme...
  • 3/28/2024 12:00:00 AM

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Scientist / Senior Scientist - Immuno-Oncology
  • Xilis, Inc.
  • Durham, NC
  • Xilis, Inc. has been developing cutting-edge Patient-Derived Micro-OrganoSpheres (MOS) technology for precision cancer d...
  • 3/28/2024 12:00:00 AM

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Associate Scientist
  • The Fountain Group
  • Morrisville, NC
  • We are a national staffing firm and are currently seeking an Associate Scientist for a prominent client of ours. This po...
  • 3/28/2024 12:00:00 AM

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HPLC Development Scientist
  • Randstad Life Sciences US
  • Durham, NC
  • 6-month contract (potential to extend or convert depending on fit) Our CDMO client delivers process development, manufac...
  • 3/25/2024 12:00:00 AM

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Analytical Scientist
  • Zenith LifeScience
  • Durham, NC
  • The role is primarily lab-based, supporting the inhalation product development (IPD) analytical sciences group conductin...
  • 3/24/2024 12:00:00 AM

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Analytical Scientist
  • GForce Life Sciences
  • Durham, NC
  • The role is primarily lab-based, supporting the inhalation product development (IPD) analytical sciences group conductin...
  • 3/24/2024 12:00:00 AM

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Associate Scientist
  • R&D Partners
  • Holly Springs, NC
  • Job Description Job Description Your main responsibilities as a Scientific Technician: · Develop methods using HPLC/UPLC...
  • 3/24/2024 12:00:00 AM

Durham is a city in and the county seat of Durham County in the U.S. state of North Carolina. The U.S. Census Bureau estimated the city's population to be 251,893 as of July 1, 2014, making it the 4th-most populous city in North Carolina, and the 78th-most populous city in the United States. Durham is the core of the four-county Durham-Chapel Hill Metropolitan Area, which has a population of 542,710 as of U.S. Census 2014 Population Estimates. The US Office of Management and Budget also includes Durham as a part of the Raleigh-Durham-Chapel Hill Combined Statistical Area, which has a populatio...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Scientist - Biotech jobs
$98,537 to $121,651
Durham, North Carolina area prices
were up 1.5% from a year ago

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