Validation & Instrumentation Specialist (Pharmaceuticals)

1 month ago

Iron Station, United States Element Staffing Full time
Job DescriptionJob Description

Basic Purpose: Drives equipment implementation and upgrades within QC. Coordinate activities with plant metrology. Perform installation/qualification/validation/verification activities including writing, reviewing, and approval of protocols and reports. Assist with purchase of new instrumentation including obtaining quotes, completing CAPEX documentation, and providing budget planning regarding equipment needs. Assist with troubleshooting instrumentation issues and space planning with the QC Laboratories.

Essential Functions and Responsibilities:
• Drive all activities for validation, qualification, and implementation of new equipment and/or upgrades to existing equipment with QC to ensure timely implementation.
• Work cross functionally with Metrology, Engineering, QA, and IT.
• Perform accurate and timely review of calibration entries in ProCal.
• Communicate with QC & QA as necessary.
• Prepare, review, and/or approve engineering change controls (ECC), instrument methods, specifications, protocols, and instrument related SOPs.
• Execute IQ/OQ/PQ
• Provide coaching to groups and provide technical guidance.
• Manage outside contract personnel assisting with equipment implementation/upgrades.
• Assist with the purchase of new equipment.
• Other duties as assigned by QC Manager

Knowledge, Skills, Qualifications and Physical Requirements:

Education/Training/Work Experience:
• MS in Chemistry or related scientific field and five years of validation experience in a GMP regulated industry; BA/BS in Chemistry or related scientific field and eight years of validation experience in a GMP regulated industry.
• Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements
• Demonstrate ability to manage projects while executing work to meet established deadlines.
• Demonstrate knowledge of technical aspects of instrument qualifications including protocol writing, execution, and troubleshooting.

Specialized Knowledge and Skills:
• Analytical/technically minded.
• Quality driven
• Proficient in technical writing
• Ability to multi-task under stress of multiple priorities
• Good oral and written communication skills
• Good organizational and people skills

Equipment and Applications:
• IR
• UV/Vis
• HPLC
• GC
• Empower Software
• Dissolution
• Karl Fischer

Work Environment and Physical Demands:
• Lab coat
• Safety glasses
• Gloves
• Ability to occasionally lift 50 pounds

Company DescriptionElement Staffing Services is an industry-leading, scientific and technical staffing company, offering contract, contract to hire, direct placement, and payroll services to companies and organizations within the Petrochemical, Specialty Chemical, Oil and Gas, Biotechnology, Pharmaceutical, Material Science, Food and Beverage, Consumer Care, Medical and Clinical Research Industries. Element's mission is to become a trusted partner by providing the most qualified scientific and technical talent for our clients and by creating pathways for career advancement for our candidates. We promise to deliver results while always abiding by our core principles of integrity, professionalism, and excellence.Company DescriptionElement Staffing Services is an industry-leading, scientific and technical staffing company, offering contract, contract to hire, direct placement, and payroll services to companies and organizations within the Petrochemical, Specialty Chemical, Oil and Gas, Biotechnology, Pharmaceutical, Material Science, Food and Beverage, Consumer Care, Medical and Clinical Research Industries. Element's mission is to become a trusted partner by providing the most qualified scientific and technical talent for our clients and by creating pathways for career advancement for our candidates. We promise to deliver results while always abiding by our core principles of integrity, professionalism, and excellence.

  • Validation and Instrumentation Specialist

    2 months ago

    Iron Station, United States Joulé Full time

    Job Title: Validation and Instrumentation Specialist Location: Iron Station, NC area Schedule / Hours: Monday - Friday, Full Time, Day Shift Type: Direct Hire Responsibilities Drives equipment implementation and upgrades within QC. Coordinate activities with plant metrology. Perform installation/qualification/validation/verification activities...

  • Quality Control Instrumentation Validator

    1 week ago

    Iron Ridge, Wisconsin, United States Element Staffing Full time

    Job OverviewPrimary Objective: The role focuses on facilitating the implementation and enhancement of equipment within Quality Control (QC). This includes coordinating with plant metrology and executing installation, qualification, validation, and verification tasks. Responsibilities also encompass assisting in the procurement of new instruments, including...

  • Compliance Validation Specialist

    1 week ago

    College Station, Texas, United States CPMNA Full time

    Job OverviewThe Validation Engineer at CPMNA will operate under general supervision, focusing on the creation and implementation of validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE). This role includes the preparation of comprehensive validation reports.Key Responsibilities:Develop, secure approvals for, and execute validation...

  • Computer System Validation Specialist

    2 weeks ago

    College Station, Texas, United States Ellab - Validation & Monitoring Solutions Full time

    Exciting Career Opportunity at Ellab - Validation & Monitoring SolutionsWe are looking for a Computer System Validation/Data Integrity Specialist to become a vital part of our dynamic organization and engage in a rewarding professional journey.As a leader in our industry, Ellab is dedicated to offering exceptional benefits that distinguish us from the...

  • Validation Engineer

    2 months ago

    College Station, United States Ellab - Validation & Monitoring Solutions Full time

    Exciting Opportunity at Ellab - Join Our Team! We're seeking a Validation Engineer to join our vibrant team and embark on an exciting journey with us.As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy: ️ Time to Unwind:Kick off your journey with 2 weeks of vacation (3 weeks at your...

  • Validation Engineer

    2 months ago

    College Station, United States Ellab - Validation & Monitoring Solutions Full time

    🌟 Exciting Opportunity at Ellab - Join Our Team! 🌟We're seeking a Validation Engineer to join our vibrant team and embark on an exciting journey with us.As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy:🏖️ Time to Unwind:Kick off your journey with 2 weeks of vacation (3...

  • Validation Specialist

    2 weeks ago

    College Station, Texas, United States Metric Bio Full time

    About the RoleMetric Bio is seeking a highly skilled Validation Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our computerized systems and processes.Key ResponsibilitiesValidation Management: Lead the development, approval, and execution of validation deliverables for...

  • Instrumentation Calibration Specialist

    2 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec, a leading global provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems tailored for clients in the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services aimed at assisting clients in...

  • Validation Engineer

    1 month ago

    College Station, United States CPMNA Full time

    Job DescriptionJob DescriptionSalary: The Validation Engineer, under general direction, will be responsible for drafting and executing validation protocols for (FUSE) Facilities, Utilities, Systems and Equipment, as well as preparing validation final reports for the same. Essential Functions: Generate, obtain approvals, and execute validation deliverables...

  • Validation Engineer III

    2 months ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a Validation Engineer III to join our team. As a Validation Engineer III, you will be responsible for planning and executing validation activities for pharmaceutical manufacturing processes and equipment. The Validation Engineer III, under general direction, will be responsible...

  • Validation Engineer III

    4 weeks ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a Validation Engineer III to join our team. As a Validation Engineer III, you will be responsible for planning and executing validation activities for pharmaceutical manufacturing processes and equipment. The Validation Engineer III, under general direction, will be responsible...

  • Validation Specialist

    4 days ago

    College Station, Texas, United States Mentor Technical Group Full time

    Job SummaryMentor Technical Group is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our clients' equipment and systems throughout their lifecycle.Key ResponsibilitiesDevelop and execute commissioning, qualification, and validation protocols for...

  • Quality Assurance

    4 weeks ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a highly skilled and experienced Quality Assurance - Compliance Specialist III to join our team. The Quality Assurance Compliance Specialist III - QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports,...

  • Quality Assurance

    1 month ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a highly skilled and experienced Quality Assurance - Compliance Specialist III to join our team. The Quality Assurance Compliance Specialist III - QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports,...

  • Validation Specialist

    3 months ago

    College Station, United States Mentor Technical Group Full time

    Job DescriptionJob DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and...

  • Validation Specialist

    3 months ago

    College Station, United States Mentor Technical Group Full time

    Job DescriptionJob DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and...

  • Quality Assurance Validation Specialist

    1 week ago

    College Station, Texas, United States CPMNA Full time

    Job OverviewThe Validation Engineer, under general supervision, is tasked with the creation and implementation of validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE). This role also involves the preparation of comprehensive validation reports.Key Responsibilities:Develop, secure approvals for, and execute validation documentation...

  • Quality Assurance Specialist II, Validation

    5 days ago

    College Station, Texas, United States Fujifilm Full time

    Job SummaryFujifilm is seeking a highly skilled Quality Assurance Specialist II, Validation to join our team. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and Batch...

  • Quality Assurance Specialist II, Validation

    2 hours ago

    College Station, Texas, United States Fujifilm Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist II, Validation to join our team at Fujifilm. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and...

  • Validation Engineer

    2 weeks ago

    College Station, Texas, United States Salent Solutions Full time

    Job OverviewPosition: Validation EngineerCompany: Salent SolutionsCompensation: Commensurate with ExperienceAbout the Role:Salent Solutions specializes in providing commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment lies in delivering exceptional service to organizations that manufacture...