Jobs
>
Trenton

    Senior Equipment Validation Engineer - Trenton, United States - Rbw Consulting

    Rbw Consulting
    Rbw Consulting Trenton, United States

    1 month ago

    Show more Collapse job
    Default job background
    Description
    RBW Consulting are excited to present an opportunity for a

    Senior Validation Engineer

    with a CDMO partner of ours


    With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products, with a particular focus on Injectables.


    Dedicated to quality and growth, our partner continually seeks to improve, over the past 5 years they have invested over $100M into their facilities to improve capabilities and expand capacity.

    Allowing you to work on large-scale projects and expand your own experience in a complex area.

    Responsibilities

    Technical Expertise :
    Provide in-depth technical knowledge related to equipment qualification, requalification, and sterilization processes.

    Validation Protocols and Reports :

    Develop and review validation protocols and reports for process equipment, critical utility systems, and environmental chambers during initial qualification and requalification.


    Document Preparation and Review :

    Assist in preparing and reviewing technical documents, including change controls, regulatory submissions, deviation investigations, validation protocols, summary reports, processing records, procedures, VMPs, and APRs.


    Aseptic Pharmaceutical Environment :
    Execute validation activities within an aseptic pharmaceutical environment.

    Regulatory Compliance :
    Ensure compliance with FDA, ISO, EMA, and other applicable domestic and international regulations.

    Technical Support :
    Provide technical support for start-up activities related to temperature mapping and sterilization programs.

    Requalification Activities :
    Support periodic requalification activities for production equipment and systems.

    Root Cause Investigations :
    Lead or assist in root cause investigations related to sterilization and other relevant activities.

    Data Analysis :
    Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvement.

    Cross-Functional Collaboration :

    Coordinate with cross-functional process teams to implement projects aimed at enhancing productivity, quality, and continuous improvement of sterilization processes.


    Audits and Inspections :
    Participate in equipment sterilization programs during internal and external audits, including regulatory inspections.

    Issue Resolution :

    Provide technical assistance for investigations into process/product issues, supporting validation deviations, and reviewing design requirements for products and equipment.


    Customer Interaction :
    Interface with customers during transfer discussions, project timelines, and deliverables.

    Safety Culture :
    Promote a safe working environment by adhering to safety rules and actively participating in safety-related activities.

    Requirements
    3+ years experience in Validation, including but not limited to Equipment and Sterilization
    Bachelors or master's degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree
    Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH


    If you could be interested in developing your career with a forward-thinking CDMO, please apply or reach out to me directly to organise a call.

    #J-18808-Ljbffr

    We have other current jobs related to this field that you can find below

  • Piper Companies

    Validation Engineer

    4 days ago

    Piper Companies Trenton, United States

    Piper Health and Sciences is actively seeking a Senior Validation Engineer to join a large global biotechnology company in the greater Trenton NJ area. · Responsibilities for Senior Validation Engineer: · Commissioning, qualification, and validation of biopharmaceutical manufac ...

  • Acara Solutions, An Aleron Company

    Validation Engineer

    4 weeks ago

    Acara Solutions, An Aleron Company Trenton, United States

    Acara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...

  • ESCO Lifesciences Group

    Validation Engineer

    5 days ago

    ESCO Lifesciences Group Feasterville-Trevose, United States Full time

    Validation Engineer -Laboratory/Pharma Equipment - Trevose, PA 19053. · Use your technical skills and travel the USA Employer Paid Medical InsuranceFrom $70,000/ year - Full-time, Monday to Friday. · Driver's License Required. · 85% Travel Required. · We are searching for an Inst ...

  • Kelith Group Inc

    Validation Engineer

    1 week ago

    Kelith Group Inc San Francisco, United States Permanent

    Kelith Group Inc has openings for the positions of Validation Engineer with master's degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of exp in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for vali ...

  • Merck & Co., Inc.

    Validation Engineer

    1 week ago

    Merck & Co., Inc. Lansdale, United States

    Qualifications: · Associate's degree or higher preferred with 1-2 years of experience or 4-5 years working experience in metrology/information technology / customer service or other relevant field. Experience working in a GMP environment and maintaining laboratory equipment. High ...

  • STELLAR CONSULTING GROUP LLC

    Validation Engineers

    6 days ago

    STELLAR CONSULTING GROUP LLC Philadelphia, United States

    Job Description · Job DescriptionValidation Associates is currently in search of Validation Engineers for our pharmaceutical clients nationwide, Multiple positions · All Visas Accepted- OPT/CPT/GC/USC/TN/L2- Multiple Positions- Nationwide. (US Candidates only) · We are actively ...

  • Collabera

    Validation Engineer

    1 week ago

    Collabera Lansdale, United States

    Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 20 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years of experi ...

  • Collabera

    Validation Engineer

    3 weeks ago

    Collabera Lansdale, United States

    Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 13 days, 3 hours left · Apply · Qualifications: · •Associate's degree or higher preferred with 1-2 years of ...

  • System One

    Validation Engineer

    4 weeks ago

    System One Warminster, United States

    Title: · Automation Validation Engineer - Pharmaceutical · Location: · Warminster, PA · Type: · 6 Month Contract potential for extension or hire · Schedule: · Mon-Fri Day · Overview: · Growing Pharmaceutical Company is seeking an Automation Validation Engineering Profession ...

  • Collabera

    Validation Engineer

    1 week ago

    Collabera Lansdale, United States

    Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 4 days, 3 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years of ...

  • Integrated Resources

    Validation Engineer

    1 week ago

    Integrated Resources Lansdale, United States

    Job ***** Validation Engineer - I · Location : West Point, PA 19486 · Duration : 6 Months Contract · Pay ***** $35/hr. on W2. · Job ***** · Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installatio ...

  • Sun Pharmaceutical Industries

    Validation Engineer

    1 day ago

    Sun Pharmaceutical Industries New Brunswick, United States

    Job Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    1 week ago

    Katalyst Healthcares and Life Sciences Philadelphia, United States

    Responsibilities: Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring . · Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, ...

  • Joulé

    Validation Engineer

    1 week ago

    Joulé Warminster, PA, United States

    Title: Automation Validation Engineer - Pharmaceutical · Location: Warminster, PA · Type: 6 Month Contract potential for extension or hire · Schedule: Mon-Fri Day · Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop an ...

  • Sun Pharmaceutical Industries

    Validation Engineer

    1 week ago

    Sun Pharmaceutical Industries New Brunswick, United States

    Job Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...

  • Merck & Co. , Inc.

    Validation Engineer

    1 week ago

    Merck & Co. , Inc. Lansdale, United States

    Qualifications: · Associates degree or higher preferred with 1-2 years of experience or 4-5 years working experience in metrology/information technology / customer service or other relevant field. Experience working in a GMP environment and maintaining laboratory equipment. High ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    1 week ago

    Katalyst Healthcares and Life Sciences South Plainfield, United States

    Roles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...

  • a Biopharmaceutical company based out PA

    Process Validation Engineer

    1 week ago

    a Biopharmaceutical company based out PA Philadelphia, United States

    Process Validation Engineer (Contract) · RESPONSIBILITIES · Overseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility. · Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, an ...

  • Planet Pharma

    Senior Validation Engineer

    1 day ago

    Planet Pharma Philadelphia, United States

    Overview · The Senior Validation Engineer is responsible for supporting the qualification of the CGMP cell therapy manufacturing facility for the client. This position is responsible for the development and execution of validation testing and documentation for a variety of equipm ...

  • Planet Pharma

    Senior Validation Engineer

    1 day ago

    Planet Pharma Philadelphia, United States

    Senior Validation Engineer · Shift: M-F, first shift schedule, · Compensation: Base range $92K-$103K + Full benefits, Bonus, & Stock options · Location: Philadelphia, PA. · Education: Bachelor's degree in Life Sciences, Engineering or equivalent. · Top 5 Skills: · Must have prio ...