Jobs
>
Cincinnati

    Computer System Validation Engineer - Cincinnati, United States - Aprecia Pharmaceuticals

    Aprecia Pharmaceuticals
    Aprecia Pharmaceuticals Cincinnati, United States

    3 weeks ago

    Default job background
    Description
    General Purpose of Position :
    This position performs and leads computer system validation (CSV) projects including developing, authoring, and executing CSV documentation and SOPs according to ISPE GAMP 5 Validation Life Cycle. The position is responsible for the execution, tracking, and reporting on validation and qualification projects. The role partners cross-functionally at the site to create, administer, and improve computerized system validation deliverables to maintain data integrity, supporting ALCOA+ principles throughout the CSV lifecycle.

    Primary Duties and Responsibilities (Essential Functions) :
    Duties/Responsibilities 1 Plan, coordinate, and execute computer system validation projects according to Aprecia policies and procedures, as well as regulatory requirements. 2 Perform risk assessments and ensure appropriate test plan development, test execution, data analysis, and report writing. 3 Collaborate to develop, maintain, and improve validation master plans, CSV protocols, reports, risk assessments, gap analyses, traceability matrices, SOPs, and other validation documents for the Aprecia site. 4 Perform testing of computerized systems, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise resource planning (ERP), building automation systems (BAS), and electronic batch records (EBR) using manual or automated methods. 5 Review and approve validation deliverables from vendors or contractors. Author cover/gap protocols for vendor supplied Commissioning & Qualification documents and provide oversight for vendor executed test scripts. 6 Use risk analysis to ensure appropriate parameters are evaluated with the required statistical approach to associated testing for justification and support of critical process parameters and quality attributes. 7 Monitor and audit the performance, compliance, and data integrity of the computerized systems on a periodic basis. Assess the need to update or requalify/revalidate systems as necessary, due to changes or upgrades. 8 Lead projects in cross-functional teams to ensure the overall success of a Validation & Qualification projects. Work with Validation management to provide cross-functional leadership to ensure project goals are met. 9 Work with internal stakeholders and vendors to plan for validation activities for new equipment and software upgrades including review of vendor supplied protocols, design specifications, configuration specifications, and qualification documents. 10 Help communicate Computer System Validation approaches and requirements during audits and inspections. 11 Other duties as required.
    Reporting to this Position :
    No direct reports.

    Travel :
    Position may require up to 10% travel.

    Work Shift :
    This position works days.

    Knowledge, Skills and Abilities :
    • Superior project management skills
    • Strong oral and written communication skills across diverse levels of the organization
    • Strong organization, relationship-building, and leadership skills
    • Ability to work independently or as part of a cross-functional team under deadlines and changing priorities
    • Strong problem-solving, critical thinking, and math skills
    • Ability to perform long-range planning in a team environment
    • Ability to collaborate and negotiate successfully in a team environment
    • Willingness to work extended hours to complete job responsibilities
    • Expert working knowledge of Microsoft Office, Microsoft Project, and related computer programs required
    Education and Experience :
    • Minimum Bachelor's degree in Engineering, Science, Math, or Computer Science, or related discipline. Master's degree is a plus.
    • Minimum 5 years of experience in computer system validation in the pharmaceutical or biotechnology industry.
    • Excellent knowledge of current good manufacturing practices (cGMP) and good automated manufacturing practices (GAMP). Familiar with 21CFR and Annex 11.
    • Experience with various computerized systems such as LIMS, MES, ERP, EBR and their validation tools and methodologies.
    • Proficient in writing clear, concise, and accurate validation documents (e.g., URS/FS, Trace Matrices).
    • Strong risk analysis, problem-solving, and troubleshooting skills.
    • Proficient knowledge of ALCOA+ and Data Integrity principles.
    • Working knowledge of the manufacturing, packaging, laboratory, and quality systems/processes needed to develop and produce OSD pharmaceutical products required.
    Physical Demands and Work Environment :
    • Ability to sit for extended periods to perform job responsibilities at a desk or meeting table.
    • Good manual dexterity to operate computer, keyboard, and general office equipment.
    • Good eyesight to read technical/instructional materials and electronic communications.
    • Good hearing to address questions during presentations, to facilitate team discussion, etc.
    • Occasional odd body positions (reaching, twisting, bending) in the performance of job duties.
    • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes).
    GENERAL INFORMATION :
    The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.

    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
  • Thermo Fisher Scientific

    Validation Engineer

    3 weeks ago

    Thermo Fisher Scientific Cincinnati, United States

    Job Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...

  • Thermo Fisher Scientific

    Validation Engineer

    1 week ago

    Thermo Fisher Scientific Cincinnati, United States

    Job Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...

  • Fowler Placement Services

    Lead Validation Engineer

    3 weeks ago

    Fowler Placement Services Cincinnati, United States

    Location · Cincinnati, OH · **Responsibilities:** · The holder of this position is charged with leading validation effort to prove control of the critical aspects of company operations, related to process, cleaning, or other elements. · * Serve as a subject matter expert in proc ...

  • Katalyst HealthCares & Life Sciences

    Sr. Validation Engineer

    1 week ago

    Katalyst HealthCares & Life Sciences Cincinnati, United States

    Responsibilities: Designing validation plans · Direct experience and understanding of complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators. · Conducting and documenting impact and risk assessments with a full understanding of equip ...

  • Tata Consultancy Services

    Equipment Validation Engineer

    4 weeks ago

    Tata Consultancy Services Cincinnati, United States

    · •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industry · GoodProject Management experien ...

  • Tata Consultancy Services

    Equipment Validation Engineer

    3 weeks ago

    Tata Consultancy Services Cincinnati, United States

    · •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industry · GoodProject Management experien ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer, Packaging Equipment

    3 weeks ago

    Katalyst Healthcares and Life Sciences Cincinnati, United States

    his position will provide planning and implementation support for the Akamai Global Communications team, including external and internal communications, industry analyst relations, and reputation management, with a focus on improving systems and processes. The Senior Specialist w ...

  • Thermo Fisher Scientific

    Validation Engineer

    3 weeks ago

    Thermo Fisher Scientific Union, United States

    As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cl Validation Engineer, Validatio ...

  • Thermo Fisher Scientific

    Validation Engineer

    3 weeks ago

    Thermo Fisher Scientific Union, United States

    Job Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...

  • Ssgnetwork

    Lead Validation Engineer

    3 weeks ago

    Ssgnetwork Union, United States

    Location Cincinnati, OH · **Responsibilities:** · The holder of this position is charged with leading validation effort to prove control of the critical aspects of company operations, related to process, cleaning, or other elements. · Serve as a subject matter expert in proces ...

  • Tata Consultancy Services

    Equipment Validation Engineer

    3 weeks ago

    Tata Consultancy Services Union, United States

    · •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industryGoodProject Management experience · ...

  • Tata Consultancy Services

    Equipment Validation Engineer

    5 days ago

    Tata Consultancy Services Union, United States

    · •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industry · GoodProject Management experi ...

  • Tata Consultancy Services

    Equipment Validation Engineer

    3 weeks ago

    Tata Consultancy Services Union, United States

    · •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industryGoodProject Management experience · ...

  • Aprecia Pharmaceuticals

    Computer System Validation Engineer

    3 weeks ago

    Aprecia Pharmaceuticals Blue Ash, United States

    General Purpose of Position · : · This position performs and leads computer system validation (CSV) projects including developing, authoring, and executing CSV documentation and SOPs according to ISPE GAMP 5 Validation Life Cycle. The position is responsible for the execution, ...

  • Actalent

    Quality Technician

    1 week ago

    Actalent Cincinnati, United States Full time

    Looking for a Lab Technician interested in working for a local brewery company You'll be working both in the lab, as well as the production floor. They will be tasked with grabbing samples, and batches, from the production lines and kegs. · Description: · Position Overview: · The ...

  • Penske Truck Leasing

    Diesel Technician/Mechanic III

    2 weeks ago

    Penske Truck Leasing Cincinnati, United States Full time

    Work Location: 2528 Commodity Circle Cincinnati, OH, 45241 · What's the Job? · Ready to accelerate your career while helping our customers move forward? As a Technician at Penske, you'll do exactly that. Here, you'll do preventative maintenance and minor repairs on the newest and ...

  • Harrison Consulting Solutions

    Municipal Engineer

    2 weeks ago

    Harrison Consulting Solutions Cincinnati, United States

    A growing and innovative multi-disciplined engineering firm is looking to add a Municipal Engineer to their Cincinnati team · Responsibilities · Ensure designs are complete/accurate · Provide direction to assigned staff and assist with goals · Ensure compliance with regulatory/pe ...

  • University of Cincinnati

    Post Doc Fellow, Department of Chemical and

    4 days ago

    University of Cincinnati Cincinnati, United States

    Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Tim ...

  • The Davey Tree Expert Company

    Telecommunications Lineman Uam Construction Services

    4 days ago

    The Davey Tree Expert Company Cincinnati, United States

    Telecommunications Lineman | UAM Construction Services · **Additional Locations**: Dayton, OH · **Primary Locations**:OH, Cincinnati, 4435 Aicholtz Rd. Ste. 700, 45245 · **Requisition ID**:196027 · **Position Overview**: · DRG is looking for a Telecom Aerial Lineman who will be r ...

  • Apex Ventures

    Digitalization and Process Coordinator

    3 weeks ago

    Apex Ventures Kenton, United States

    YOUR RESPONSIBILITIES · Responsibility and coordination for all topics in the field of process management and digitalization · Validation, continuation and implementation of the digitalization potential already identified in the company · Development of a digitalization strategy ...