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Validation Engineer (Cleaning Validation)

Validation Engineer (Cleaning Validation)

Sern BioScienceBend, OR, US
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Validation Engineer (Cleaning Validation).Sern BioScience is seeking a Validation Engineer to support the cleaning verification and validation program for clinical phase testing of novel pharmaceut...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Hims & HersGilbert, Arizona, USA
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Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Fresenius Kabi USA, LLCWilson, NC, United States
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Responsible for providing technical support to operations in terms of equipment / system initial validation and equipment / system requalification's. Will participate in equipment improvement teams char...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Tri-Pac IncSouth Bend, IN, US
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Validation Engineer Tri-Pac, Inc.CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Validation Engineer.The Validation Engi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer

Validation Engineer

Katalyst Healthcares & Life SciencesDallas, TX, US
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Responsibilities : Develop, execute, and document test method validation protocols to ensure accuracy, precision, and reliability of testing procedures. Lead validation activities for new or existing...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Motion RecruitmentPlymouth, MI, US
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We are hiring a skilled Hardware Validation Engineer with expertise in automotive testing, fixture design, and cross-functional collaboration to support cutting-edge vehicle programs.Job Title : Har...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Technoviz LLCMADISON, WI, US
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IT projects and change control initiatives.The ideal candidate will have a strong foundation in computer systems validation, quality assurance, and regulatory compliance, particularly in pharmaceut...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation Engineer

Validation Engineer

AptivWarren, OH, United States
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Important Company Update - Please Read Before Applying.On January 22, 2025, Aptiv announced its decision to separate its EDS division to form two separate independent companies : .This role is within...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer

Validation Engineer

hims & hersGilbert, AZ, US
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Pharmaceutical Validation Engineer.Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer

Validation Engineer

E-SolutionsNorth Haven, CT, US
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Benefits : Medical, Dental, Vision, 401K Plan, PTO.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer

Validation Engineer

FlextronicsLibertyville, IL, US
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To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Validation Engineer located in Libertyville, IL. Reporting to the Quality Manager, th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

PSC BiotechColumbus, OH, us
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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 appl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation Engineer

Validation Engineer

MedPharmDurham, NC, US
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Validation / Process Engineer Date : XXX Site : Durham, NC FLSA Status (US Only) : Exempt / Non-Exempt Department : Manufacturing Reporting To : (Title) Position Summary Medpharm seeks a talented Vali...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Packaging Engineer

Packaging Engineer

Sterling Engineering Inc.Knoxville, TN, US
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Food & Beverage Manufacturing.Medical, Dental, Vision, PTO, 401K.We are seeking a Packaging Engineer to lead the development, qualification, and optimization of primary, secondary, and tertiary...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Validation Engineer

Validation Engineer

ACL DigitalLa Verne, CA, US
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Independent engineer with in-depth knowledge about validation lifecycle management and able to write VMP, protocols and corresponding summary reports. Able to execute test protocols independently an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Quality Chemical LaboratoriesWilmington, NC, US
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Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer.This posit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Validation Engineer

Validation Engineer

PrideStaffFairfield, NJ, US
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Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position.Responsible for Validation / PPAP Packages on new customer programs, as well as ensuring compliance is applic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Validation Engineer

Validation Engineer

Tech DigitalSummit, NJ, US
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Job Description : 50% onsite required Work schedule - M-F(Should be flexible on timings based on business needs) PURPOSE AND SCOPE OF POSITION : The Csv Engineer supports the successful implementatio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Piper CompaniesSilver Spring, MD
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Piper Companies is currently looking for an experienced.Silver Spring, MD, to work for an innovative and growing pharmaceutical organization. Responsibilities for the Validation Engineer include : .As...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer

Validation Engineer

Millennium Software and Staffing IncSanta Clara, CA, US
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Looking for Emulation Validation Engineer with following skills / experience -.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Engineer (Cleaning Validation)

Validation Engineer (Cleaning Validation)

Sern BioScienceBend, OR, US
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Validation Engineer (Cleaning Validation)

Sern BioScience is seeking a Validation Engineer to support the cleaning verification and validation program for clinical phase testing of novel pharmaceutical drug products.

The Validation Engineer will be responsible for developing and executing commissioning and qualification protocols for equipment and systems and performing validation studies for process, cleaning, computerized systems, and critical utilities needed to support clinical and commercial distribution of non-sterile Oral Solid Dosage pharmaceutical products. Initial focus will be to evolve and manage a cleaning verification and validation program for clinical drug product production.

Duties and Responsibilities

  • Evolve and manage cleaning verification / validation program for clinical supply manufacturing facility
  • Leads and supports projects for new product introduction, tech transfer, product / process optimization in a clinical manufacturing facility for oral solid dose products
  • Authors and executes commissioning, qualification, and validation protocols and reports
  • Defines and coordinates execution of cleaning development studies for manufacturing equipment
  • Facilitates and drafts risk assessments with interdisciplinary teams related to equipment design, operation, and cleaning processes
  • Leads continuous improvement initiatives related to manual and automated cleaning processes
  • Defines and tracks metrics to assess cleaning program effectiveness and efficiency
  • Leads and supports investigations related to process equipment operations and cleaning processes
  • Supports capital projects and implementation of new technologies
  • Responsibilities may increase in scope to align with company initiatives
  • Performs other related duties as assigned

Required Skills and Abilities

  • Knowledge of FDA cGMP guidelines and regulations acquired through education, experience, and training; additional knowledge of global regulatory requirements highly desirable (E.g., MHRA / EMEA)
  • Understanding of the Compliance and Technical requirements on the application of various scientific concepts used for developing different dosage forms of pharmaceutical products (primarily oral solid dose)
  • Familiarity with water systems, CIP, Part Washers, and OSD process equipment
  • Hands on experience with execution of cleaning verification studies and sampling methods (swab, rinse, visual, etc.)
  • Proven experience with cleaning validation, protocol development, execution, troubleshooting, and summary reports
  • Effective written, oral, and interpersonal communication skills
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Strong time-management skills and the ability to organize and coordinate multiple projects at once
  • Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

    • Education and Experience

  • Bachelor's degree in engineering or related technical field
  • A minimum of 3 years of experience with pharmaceutical manufacturing, engineering, validation, or other relevant experience in cGMP environment

    • Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • Prolonged periods of sitting or standing in a manufacturing environment
  • Must be able to lift fifteen pounds at times
  • Adheres to consistent and predictable in-person attendance