Current jobs related to validation engineer ii - Summerville, South Carolina - Thorne Research, Inc.

  • Project Engineer II

    3 weeks ago

    Summerville, South Carolina, United States Booth and Associates Full time

    Job Type Full-time Description Engineer II performs a variety of routine tasks, which provide experience and familiarity with engineering staff, methods, practices and programs. Engineer II works under close supervision but is expected to have some level of independence with required engineering tasks. Requirements Position requirements include: Assist in...

  • Civil Project Engineer II

    7 days ago

    Summerville, South Carolina, United States CEMS Engineering Inc Full time

    Job Overview:Civil Project Engineers at CEMS Engineering Inc play a critical role in the development of civil site projects. This position is responsible for preparing plans, conducting hydrology and hydraulic studies, creating drainage reports, site plans, technical specifications, grading and utility plans, erosion control plans, and roadway...

  • Civil Project Engineer II

    7 days ago

    Summerville, South Carolina, United States CEMS Engineering Inc Full time

    Position The successful candidate's responsibilities will include preparation of plans for civil site projects. Typical tasks include hydrology and hydraulic studies, drainage reports, site plans, technical specifications, grading and utility plans, erosion control plans and roadway design. Responsibilities will expand as experience is gained. Job Location...

  • Shop Technician II

    4 hours ago

    Summerville, South Carolina, United States Blanchard Machinery Full time

    Shop Technician IIJob LocationsUS-SC-SummervilleID2025-3005# of Openings1TypeFull-TimeOverviewThe Shop Technician II is responsible for performing jobs involving servicing and repair of all types of mechanical, hydraulic and diesel-powered equipment, working both independently and on a team. On the job training, classroom instruction, and e-learning will...

  • Project Engineer III

    4 weeks ago

    Summerville, South Carolina, United States Booth and Associates Full time

    Job Type Full-time Description Occupational Summary: Mentor small team of engineers and CAD designers in General/Physical Layout as well as Protection & Control packages of substation design projects. Candidate will be the sealing engineer for the majority of work produced by the team and will also act to manage customer relations and well as business...

  • Project Engineer III

    1 day ago

    Summerville, South Carolina, United States Booth and Associates Full time

    Job Type Full-timeDescriptionOccupational Summary: Mentor small team of engineers and CAD designers in General/Physical Layout as well as Protection & Control packages of substation design projects. Candidate will be the sealing engineer for the majority of work produced by the team and will also act to manage customer relations and well as business...

  • Data Analyst II

    1 week ago

    Summerville, South Carolina, United States Advanced Technology International Full time

    Data Analyst IIVacancy No VN588Employee Type Full-timeLocation City SummervilleEducation Level Bachelor's DegreeExperience Level 5 yearsJob DetailsATI builds and manages collaborations that conducts research and development of new technologies to solve our nation's most pressing challenges. Our collaborations are custom-built teams of organizations from...

  • engineer

    2 weeks ago

    Summerville, South Carolina, United States Thorne Research Full time

    At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of...

  • Diesel Technician II

    1 week ago

    Summerville, South Carolina, United States Knight's Companies Full time

    Job Type Full-time Description The Diesel Technician II is responsible for performing maintenance and repairs on diesel and non-diesel vehicles and heavy equipment to sound, safe, and reliable performance of the vehicle and/or equipment, as well as provide guidance and assistance to level I Diesel Technicians. Hourly + $1,000.00 Sign- On BonusDuties: Change...

  • Diesel Technician/Mechanic II

    14 hours ago

    Summerville, South Carolina, United States Penske Full time

    3166 Ancrum Rd. Ladson, SC 29456 $5,000 Sign On Bonus What's the Job? Ready to move your career forward? As a Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on...

  • Data Analyst II

    1 week ago

    Summerville, South Carolina, United States ATI | Advanced Technology International Full time

    ATI builds and manages collaborations that conducts research and development of new technologies to solve our nation's most pressing challenges. Our collaborations are custom-built teams of organizations from industry and academia that develop novel technologies for the federal government. Traditionally, these processes are complicated and burdensome.That's...

  • Electrical Engineer IV

    3 weeks ago

    Summerville, South Carolina, United States Markem-Imaje Full time

    Electrical Engineer IV at Markem-Imaje summary:The Electrical Engineer IV at Markem-Imaje is responsible for the analysis, design, testing, and troubleshooting of electronic systems and products. This role involves collaborating with cross-functional teams to ensure product performance and addressing customer requirements, while leading development efforts...

  • Electrical Engineer IV

    2 weeks ago

    Summerville, South Carolina, United States Markem-Imaje Full time

    Electrical Engineer IV at Markem-Imaje summary:The Electrical Engineer IV at Markem-Imaje develops innovative electronic products and systems, focusing on ensuring product quality and compliance with customer requirements. This role involves collaboration across various engineering disciplines to design, test, and troubleshoot advanced electronic solutions,...

  • Mechanical Systems Engineer

    13 hours ago

    Summerville, South Carolina, United States Xylem Full time

    Required Skills and QualificationsTo be successful in this role, you will need:A high school diploma or equivalentA valid driver's license with a good driving record (Class B CDL preferred)The ability to pass a background check, drug screen, MVR check, and DOT physicalExperience working with diesel systems, or a combination of education, training, and...

  • Diesel Technician

    2 weeks ago

    Summerville, South Carolina, United States Cummins Full time

    **DESCRIPTION** We are looking for a talented Diesel Technician to join our team specializing in engine repairs for our Distribution Business in Summerville, SC. $5000 Sign on Bonus In this role, you will make an impact in the following ways: + Complete troubleshooting, repairs and rebuilds on engine products and other customer equipment in a service shop. +...

  • Manufacturing Engineer

    4 weeks ago

    Summerville, South Carolina, United States Actalent Full time

    Identify areas for improvement, develop and implement tooling and fixturing improvements Manage industrialization projects of new developed equipment in a cross-functional team environmen Develop new and improve existing workstation layouts to support lean and efficient assembly processes, as well as improved ergonomics for shop floor employees Support...

  • Diesel Engine Mechanic

    3 days ago

    Summerville, South Carolina, United States Blanchard Machinery Full time

    About the JobWe are seeking a highly skilled Shop Technician II to join our team at Blanchard Machinery Company. As a key member of our maintenance team, you will be responsible for performing complex repairs and maintenance on various types of heavy equipment.This is an excellent opportunity for individuals who enjoy working with their hands,...

  • Manufacturing Engineer

    4 weeks ago

    Summerville, South Carolina, United States Actalent Full time

    Job Details: Identify areas for improvement, develop and implement tooling and fixturing improvements. Manage industrialization projects of newly developed equipment in a cross-functional team environment. Develop new and improve existing workstation layouts to support lean and efficient assembly processes, as well as improved ergonomics for shop floor...

  • Lead Engineer

    2 weeks ago

    Summerville, South Carolina, United States Hobbs Brooks Full time

    Lead Engineer at Hobbs Brooks summary:The Lead Engineer at Hobbs Brook oversees maintenance and operations of commercial office and laboratory facilities, ensuring a reliable environment for tenants. This role involves providing leadership and mentorship to junior engineers, performing complex maintenance on MEP systems, and implementing preventive...

  • Lead Engineer

    2 weeks ago

    Summerville, South Carolina, United States Hobbs Brooks Full time

    Lead Engineer at Hobbs Brooks summary:The Lead Engineer at Hobbs Brook oversees maintenance and operations of commercial office and laboratory facilities, ensuring a reliable environment for tenants. This role involves providing leadership and mentorship to junior engineers, performing complex maintenance on MEP systems, and implementing preventive...

validation engineer ii

1 week ago

Summerville, South Carolina, United States Thorne Research, Inc. Full time
At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 550 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY: The Validation Engineer II supports commissioning and qualification activities associated with cGMP equipment acquisition, installation, operation, and facility modification. The Validation Engineer II will lead verification activities in alignment with Thorne Cleaning/Validation Master Plan to ensure that all cGMP equipment is installed and maintained in a qualified state. The Validation Engineer II works in partnership with the Engineering management, Engineering Staff (Engineers and Technicians), Quality Assurance, and Equipment System Owners to develop and oversee the commissioning and qualification and validation strategy for all equipment and processes.

RESPONSIBILITIES - Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.
  • Supports or responsible for overall supervision and oversight during execution of validation activities (for example observation of production personnel performing cleaning process and the monitoring and recording of observed values concurrent with cleaning event).
  • Writes and provides training on SOPs relevant to validation procedures.
  • Knowledgeable of current regulatory guidelines and industry standards pertaining to cleaning validation.
  • Assists in writing regulatory documents for regulatory agency submission.
  • Under the guidance of Thorne Quality, interacts with regulatory authorities regarding validation compliance issues and regulatory requirements. Perform other qualification and validation activities as assigned by the Engineering Manager or Validation Manager.
  • Works on other Validation Engineering projects as assigned by Manager.
  • Equipment Qualification and Process Validation:
  • Assists in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assists in the development and review of User Requirements Specifications (URS).
  • Facilitates formal quality risk assessments. Suggests design modifications to address risks and design in quality and safety.
  • Assists in developing commissioning strategies based on the URS and Risk Assessment to verify equipment design while minimizing project cost and schedule impact (risk-based approach).
  • Develops, writes, and executes protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Supports periodic review of manufacturing systems to ensure that equipment remains in a qualified state and that processes remain in a validated state.
  • Assists in all aspects of Process Validation including providing process risk assessments and authoring, writing, and reviewing validation protocols and reports.
  • Leads Continuous Process Verification activities to assure processes remain in a validated state.
Cleaning Validation:
  • Assists with all aspects of Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
  • Writes, reviews and/or revises site Cleaning Validation Master Plan.
  • Performs sampling for cleaning studies and/or continuous monitoring/verification activities, including the collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing.
  • Coordinates and schedules cleaning validation and/or continuous monitoring/verification activities with appropriate departments.
  • Assists in the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.
  • Evaluates cleaning procedures and revises with process improvements as necessary.
  • Trains other personnel on rinse sampling and surface swab sampling.
  • Writes, reviews, and executes cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
  • Assists in summarizing results and conclusions when writing final reports.
  • Ensures final reports and study data is reviewed and approved in a timely manner after execution is completed.
  • Develops clean/dirty hold times.
What You Need:

Education and/or Experience - Bachelor's degree in an applicable engineering or scientific field, with documented combination of education and experience readily available years' hands-on experience in process development, production support, manufacturing engineering, or another relevant field in an FDAregulated environment is required.

What We Offer:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:
  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • Company-paid short- and long-term disability insurance
  • Company- paid life insurance
  • 401k plan with employer matching contributions up to 4%
  • Gym membership reimbursement
  • Monthly allowance of Thorne supplements
  • Paid time off, volunteer time off and holiday leave
  • Training, professional development, and career growth opportunities
  • A safe and clean work environment
A little bit more about us.

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne owns every step of its business, from R&D to product delivery and customer service. Currently, we are:
  • The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.
  • The #1 prescribed practitioner brand to 30 to 40-year-olds.
  • The #2 most dispensed supplement brand.
  • The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.
If you want to make a difference in the lives of others consider becoming part of the Thorne team.

"Must be able to safely work with ingredients and products that are derived from possibly allergenic sources including, but not limited to, nuts, soy, dairy, fish, and shellfish."

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER